Job Title: Scientist, Process Development

We are currently seeking a Process Development Scientist to join the Forge Biologics team. This is an exciting opportunity to provide supervision and oversight of (upstream/downstream) Process Development. The candidate will lead implementation of new technologies and systems into research and GMP operations. The ideal candidate will be an expert in technical problem-solving and developing interdepartmental/interorganizational relationships to support our growth in the Gene Therapy sector.

The PD Scientist is responsible for developing the clinical/commercial process(es) for our most advanced AAV-based (viral vector) therapeutic candidates. Once developed, the PD Scientist will oversee efforts to characterize and optimize that process as well as the development of subsequent manufacturing processes.

The Director of Research Manufacturing will be responsible for upstream (cell culture & virus production) and downstream (harvest & purification) activities with the goal of delivering a specified amount of AAV at the client’s request. The Director will also analyze in-process and release analytical testing. Lastly, the Director will oversee the formulation and drug production filling, finishing operations, and distribution of product to client.

The PD Scientist will be responsible for upstream (cell culture & virus production) and downstream (harvest & purification) activities with the goal of eventually developing a singular “platform” process for the entire AAV program portfolio. The PD Scientist will also oversee in-process analytical method development and testing. Lastly, the PD Scientist will oversee the formulation and drug production filling and finishing operations.

Responsibilities:

• Leads Process Development laboratory activities from upstream production optimization to fill finish processes that incorporates application of GMP principles and methodologies
• Drafting and revising process documents, manufacturing batch records, and sampling plans
• Prepares and presents data associated with manufacturing processes and transfers activities to internal and external clients. May serve as the Person-in-Plant support during manufacturing campaigns
• Support internal process transfer activities and serves as Subject Matter Expert (SME) to troubleshoot processes
• Delivering results in a high paced environment
• Conducts the engineering effort to assure process equipment and supporting materials are in place and meet GMP requirements from design through procurement, installation and operational readiness, and associated required documentation
• Additional responsibilities not listed may be assigned as needed by leadership

Requirements:

• Ph.D. or master’s degree in biological sciences or engineering (or equivalent work experience)
• Minimum of 5+ years’ experience in biopharmaceutical manufacturing/Research and Development activities preferred
• Strong knowledge in the following system(s): Cell Culture, Pharmaceutical Utilities, Purification (FPLC), Filling, Bioreactors, Automation, Process Sterilization, and Liquid Filling/Packaging
• Must be self-motivating, organized and proactive
• Strong technical aptitude including demonstrated experience in applying scientific reasoning to solve complex problems
• Ability to work hours necessary to support production and/or product transfer activities
• Ability to work in confined spaces and near operating equipment
• Ability to work in loud noise environments and in Personal Protective Equipment (PPE) and Clean Room gowning attire as needed
• Travel on an intermittent basis is required (approximately 5-10%) to support job responsibilities and commitments

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Job Title: Vice President of Medical Affairs

We are currently seeking a Vice President of Medical Affairs (VP) to join the Forge Biologics team. This is an exciting opportunity to design, build and lead the therapeutics division at Forge. The VP will report to the CEO and will be responsible for transitioning pre-clinical products into our clinical pipeline and managing the Clinical Operations team. The successful candidate will work closely with the CEO and CMO on clinical development strategy and will provide direction to senior leadership cross-functionally regarding all aspects of medical affairs. Key attributes for the role include strong knowledge in the orphan/rare disease and gene therapy space; direct experience with translation of products from bench side to bedside; and experience in interaction with regulatory agencies both in the United States and abroad.

Responsibilities:

• Create and maintain relationships with Key Opinion Leaders and related groups to educate and enhance understanding of our medical programs and research towards advances in technology and treatment across multiple disease areas.
• Develop strategic plans outlining the lifecycle of our products from preclinical research through commercialization
• Assist in preparation of regulatory documents including INDs, briefing packages, designation requests, and BLAs
• Assist in clinical protocol development, investigator brochure review, trial report preparation and data interpretation
• Support and oversight of data safety monitoring and advisory board meetings
• Participate in the hiring, training and leadership of the Clinical Operations team
• Manage budgets, resources, performance assessments, and other key business management tasks
• Develop and maintain business relationships at all levels to ensure the continued growth of business
• Ensure team activities are consistent with Forge values and aligned with our mission to accelerate transformative medicines to those who need them most
• Enable consistent dialogue and support stakeholder management to establish partnerships with alliance organizations and commercial counterparts
• 20%-40% travel anticipated

Requirements:

• Advanced degree (MD) with sciences major required
• 5-7 years clinical experience in biotech, pharmaceutical or relevant clinical CRO experience.
• Experience in execution of rare disease or gene therapy clinical trials required, including experience in both Phase 1 studies and larger, multi-center trial management
• Demonstrated experience interacting with FDA and EMA
• Well versed in GCP and applicable FDA/EMA regulations required
• Ability to prepare and present clinical trial updates to Board members and investors

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Job Title: Director, Quality Control

Reports to: Senior Director, Quality Management

We are currently seeking a Director of Quality Control to join the Forge Biologics team. In this role, the Director of Quality Control (QC) actively contributes to the strategic, operational, and laboratory activities required to support the method transfer, validation, sample testing, and review/approval of related reports. The Director manages the assets and personnel in the QC department and the QC activities for both internal and external gene therapy programs. This includes, but may not be limited to, stability testing and Drug Substance (DS)/Drug Product (DP) release.

This is an exciting opportunity to provide leadership and oversight of the required support services and systems to make our organization successful. The candidate will lead a team of scientists, analysts, and technicians to work with vendors, internal users, and external clients to support GMP and business operations. The candidate will serve to assure all groups are properly supported and integrated into new systems and communications to support future growth and the Forge strategic vision.

Working in a matrix management environment that includes Analytical Development, Clinical and Commercial Manufacturing, Quality Assurance, Regulatory Affairs, and Supply Chain, the candidate will be responsible for maintaining a detailed understanding of the status of each program in order to prioritize and effectively execute on QC-related activities.

The Director of QC will have oversite of the Analytical, Micro, Physical Monitoring, and Environmental Monitoring teams at Forge. These teams serve a wide array of internal and external customers and require close coordination with Quality and Regulatory groups as well. Additionally, the Director will set-up and maintain and trend these systems. The Director will play a crucial role in developing and maintaining these teams and will be the local subject matter expert for all regulatory inspections for these applications. Additionally, the candidate will lead/participate in addressing Regulatory Agency responses resulting from CTA/IND and BLA/MAA applications.

The Director will take part in coordinating and participating in construction efforts for continued growth of the facility as well as the continued support of the facility moving forward. The individual chosen for this position will work in close partnership with all Operations leadership, and/or external parties to support GMP manufacturing of clinical drugs. The focus of this management role is to employ learned approaches to ensure Forge provides and maintains a state of the art AAV facility for pre-clinical, clinical, and commercial viral vector products, working in close partnership with internal and external experts to realize this goal.

To this end, the Director of QC will keep current on new technologies, and regulatory requirements that may have an impact on the company’s development, while ensuring adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Role Description:

• Provides strategic and operational management of a Quality Control department responsible for performing assays relevant to viral vector/gene therapy products, including in-process testing, in-process control, lot release, and formal stability testing.
• Accountable for ensuring adherence to strict regulatory requirements to ensure product quality.
• Works with the Analytical Development (AD) organization (Assay Development, non-GMP testing group, etc.), and across the GMP Operations team more broadly, to ensure effective communication between all groups.
• Assist in clinical protocol development, investigator brochure review, trial report preparation and data interpretation
• Provides management for and ensures the effective transfer of analytical methods to Quality Control in a phase-appropriate fashion, to support pre-clinical, clinical, and commercial activities.
• Participate in the hiring, training and leadership of the Clinical Operations team
• Ensures a science-driven, phase appropriate, and risk-based Quality Control strategy to support development projects from product selection to clinical development and commercial manufacture for internal therapeutic programs.
• Contributes to authoring and/or reviewing QC reports, SOPs, QC protocols, comparability protocols and reports, justification of specifications, and relevant sections of regulatory filings.
• Ensures adherence to timelines in support of IND, BLA, and all relevant ex-US regulatory filings.
• Manages and mentors staff to build a highly functional QC team that may be cross-trained in analytical development assay areas, as needed.
• Builds the scientific knowledge, capabilities, and strategies in gene therapy QC that enable fast to clinic/fast to market product development and commercialization.
• Works directly with Senior Leadership to assure process communications are occurring in a timely manner and budget and timelines are being adhered to.
• Subject matter expert (SME) that participates in the engineering effort to assure analytical equipment and supporting materials are in place and meet current GMP requirements from design through procurement, installation and operational readiness, and associated required documentation.
• Supports business development activities including vendor and contractor selection as well as resource and response generation for bids and project budgeting.
• Supports future business evolution through process knowledge expansion and supporting internal product and process development activities.

Requirements:

PhD in molecular biology, virology, biochemistry, or related discipline and a minimum of 9 years of experience in biologics and/or gene therapy QC roles, OR Master’s degree in these same disciplines and a minimum of 10 years of relevant experience, OR Bachelor’s degree in these same disciplines and a minimum of 15 years of relevant experience.

Special Knowledge or Skills Required:

• Comprehensive experience with the analytical methods used for gene therapy in-process testing, release testing and characterization, with an emphasis on potency assays.
• Expert knowledge of cell-based assays, qPCR, HPLC, ELISA, SDS-PAGE, mass spectrometry, and molecular biology techniques.
• Expert level knowledge of CMC analytical and regulatory requirements.
• Expert level knowledge of cGMP requirements as they pertain to Analytical Development and Quality Control testing.
• Expert level laboratory skills for analysis of pharmaceuticals, biopharmaceuticals.
• Functional knowledge of mammalian cell culture.
• Prior experience with commercial release testing within CROs/CMOs.
• Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports.
• Excellent oral and written communication skills.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Ability to work hours necessary to support production and/or product transfer activities.
• Ability to present to and interact with Senior Leadership.

Special Knowledge or Skills Preferred.

• Minimum of 6+ years’ experience in leadership/management/supervision with a preference toward direct Gene Therapy/Cell Therapy industry experience.
• Small company and/or start-up experience.
• Experience in high-level interactions with domestic and international Regulatory agencies.
• Travel requirements: 0 to 15%

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Job Title: Technician, Quality Control

Reports to: TBD

We are currently seeking a Quality Control (QC) Technician to join the Forge Biologics team. This is an exciting opportunity to lead the laboratory efforts and execute characterization testing and assays for Quality Control. The candidate will optimize existing and implement new technologies and systems into Quality Control for research and GMP purposes. The ideal candidate will be skilled in technical problem-solving and laboratory techniques to support our growth in the Gene Therapy sector.

The QC Technician may be responsible for performing the in-process and release testing for our most advanced AAV-based (viral vector) therapeutic candidates generated from the PD, research, and GMP laboratories, as well as raw materials, to ensure they conform to manufacturer specifications. The QC Technician will execute the procedures designed to demonstrate safety, efficacy, and purity of the drug products under evaluation.

The QC Technician may be responsible for upstream (cell culture and virus production) and downstream (harvest and purification) testing activities to support a singular “platform” process for the entire AAV program portfolio.

Responsibilities:

• Conducts Environmental Monitoring/Microbiological, Chemistry, and/or Biochemistry testing (e.g., microbial testing, titering by PCR, etc.) that incorporates application of GMP principles and methodologies.
• Conducts thorough investigations to determine root cause of OOS investigations and other non-conforming results and implements appropriate corrective and preventative actions in a timely manner.
• Drafts and revises process documents, assay methods, and sampling plans.
• Trains junior staff in laboratory skills and scheduling lab/equipment maintenance.
• Plans work to meet production and schedule requirements from clients (internal and external).
• Prepares and presents data associated with manufacturing processes and transfer activities to clients. May serve as the Person-in-Plant (PIP) support during manufacturing campaigns.
• Reviews and trends QC data (environmental monitoring, microbiological, chemistry, and/or biochemistry) and publishes trend reports on a routine basis.
• Supports internal process transfer activities and serves as Subject Matter Expert (SME) to troubleshoot processes/assay. May also represent QC as a SME during audits and inspections.
• Delivers results in a high paced environment.
• Supports packaging and shipping finished product and/or coordinates the effort.
• Additional responsibilities not listed may be assigned as needed by management.

Requirements:

• Minimum Bachelor’s Degree (B.A. or B.S.) in scientific-related field or engineering (or equivalent work experience).
• Minimum 2 years’ experience in a Quality Control laboratory; GMP QC laboratory strongly preferred.
• Must be self-motivating, organized, and proactive.
• Strong technical aptitude, including demonstrated experience in applying scientific reasoning to solve complex problems.
• Ability to work hours necessary to support production and/or product transfer activities.
• Ability to work in confined spaces and near operating equipment.
• Ability to work in loud noise environments and in Personal Protective Equipment (PPE) and Clean Room gowning attire as needed.
• Travel on an infrequent basis is required (5%) to support job responsibilities and commitments.

Special Knowledge or Skills Preferred.

• Detailed/Demonstrated knowledge and understanding of GMP regulations and Food and Drug Administration (FDA) requirements.
• Experience with an electronic Document Management System.
• Working knowledge of global pharmacopeias such as USP, EP, JP, BP, Ph. Eur.
• Knowledge of biopharmaceutical manufacturing process workflows.
• Knowledge in the following system(s): Cell Culture and Cell-based assays, Pharmaceutical Utilities, HPLC, Microbial testing, Mass spectrometry, AUC, PCR, ELISA, and gel electrophoresis.

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Job Title: Technician, Research Manufacturing

Reports to: Manager, Research Manufacturing

We are currently seeking a Research Manufacturing Technician to join the Forge Biologics team. This is an exciting opportunity to join and execute production processes (upstream and/or downstream) for pre-clinical viral vector manufacturing. The candidate will perform biomanufacturing procedures to prepare pre-clinical vector for clients at various scales ranging from 500mL to 500L. The ideal candidate will be skilled in technical problem-solving and laboratory techniques to support our growth in the Gene Therapy sector.

This position reports to the Manager of Research Manufacturing and is responsible for the production of recombinant adeno-associated virus (rAAV) vectors via maintenance of mammalian and insect cell lines, transfection, infection, and downstream purification of rAAV by chromatography and ultracentrifugation. You will utilize shake flasks and bioreactors for scale up experiments. You will also be directly involved in scalable downstream purification technologies for rAAV using FPLC systems, tangential flow filtration, and centrifugation. Work activities will also include compiling experimental data and contributing to protocols and study reports with supervision. It is expected that you will work as a member of the production team while accomplishing the timely completion of assignments and reporting of unexpected technical issues.

Responsibilities:

• Maintain cell growth, transfection, and infection of mammalian and insect cells for baculovirus and rAAV manufacturing using shake flasks and single-use bioreactors
• Execute downstream purification technologies related to rAAV purification using chromatography (affinity and ion-exchange) and filtration processes including microfiltration, depth filtration, tangential flow filtration, and sterile filtration
• Compile experimental data with minimal oversight and contribute results for publications or reports
• Support internal process transfer activities from Process Development
• Delivering results in a high paced environment
• Maintains records and files of work and revisions.
• Package and ship finished product to clients in accordance with procedures and regulations
• Additional responsibilities not listed may be assigned as needed by leadership

Requirements:

• Bachelor’s Degree in biological sciences or engineering (or equivalent work experience)
• Technical proficiency required for aspects of cell line growth and production of biological product
• Working knowledge of upstream production techniques; experience with bioreactors is preferred
• Working knowledge of downstream purification techniques; experience with GE AKTA systems (Pure, Avant, Pilot) FPLC is preferred
• Experience with production of biologics and performing bioassays is preferred
• Must be self-motivating, organized and proactive
• Strong technical aptitude including demonstrated experience in applying scientific reasoning to solve complex problems
• Ability to work hours necessary to support production and/or product transfer activities
• Ability to work in loud noise environments and in Personal Protective Equipment (PPE) and cleanroom gowning attire as needed

Reporting Outline:

• This position reports to the Manager of Research Manufacturing
• Travel on an intermittent basis is required (approximately 5-10%) to support job responsibilities and commitments

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Job Title: Scientist, Research Manufacturing

Reports to: Manager, Research Manufacturing

We are currently seeking a Research Manufacturing Scientist to join the Forge Biologics team. This is an exciting opportunity to provide active leadership and execution of the laboratory efforts and production processes (upstream and/or downstream) for pre-clinical viral vector manufacturing. The candidate will perform biomanufacturing procedures to prepare pre-clinical vector for clients at various scales ranging from 500mL to 500L. The ideal candidate will be skilled in technical problem-solving and laboratory techniques to support our growth in the Gene Therapy sector.

This position reports to the Manager of Research Manufacturing and is responsible for the production of recombinant adeno-associated virus (rAAV) vectors via maintenance of mammalian and insect cell lines, transfection, infection, and downstream purification of rAAV by chromatography and ultracentrifugation. You will utilize shake flasks and bioreactors for scale up experiments. You will also be directly involved in scalable downstream purification technologies for rAAV using FPLC systems, tangential flow filtration, and centrifugation. Work activities will also include compiling experimental data and contributing to protocols and study reports with supervision. It is expected that you will work as a member of the production team while accomplishing the timely completion of assignments and reporting of unexpected technical issues.

Responsibilities:

• Maintain cell growth, transfection, and infection of mammalian and insect cells for baculovirus and rAAV manufacturing using shake flasks and single-use bioreactors
• Execute downstream purification technologies related to rAAV purification using chromatography (affinity and ion-exchange) and filtration processes including microfiltration, depth filtration, tangential flow filtration, and sterile filtration
• Compile experimental data with minimal oversight and contribute results for publications or reports
• Support internal process transfer activities from Process Development
• Delivering results in a high paced environment
• Package and ship finished product to clients in accordance with procedures and regulations
• Train and mentor junior laboratory technicians
• Additional responsibilities not listed may be assigned as needed by leadership

Requirements:

• Master’s Degree with 8+ years’ experience in biopharmaceutical manufacturing/Research and Development; Ph.D. in biological sciences is preferred (or equivalent work experience)
• Technical proficiency required for aspects of cell line growth and production of biological product
• Working knowledge of upstream production techniques; experience with bioreactors is preferred
• Working knowledge of downstream purification techniques; experience with GE AKTA systems (Pure, Avant, Pilot) FPLC is preferred
• Experience with production of biologics and performing bioassays is preferred
• Experience working in a cGMP environment is preferred
• Must be self-motivating, organized and proactive
• Strong technical aptitude including demonstrated experience in applying scientific reasoning to solve complex problems
• Ability to work hours necessary to support production and/or product transfer activities
• Ability to work in loud noise environments and in Personal Protective Equipment (PPE) and Clean Room gowning attire as needed

Reporting Outline:

• This position reports to the Manager of Research Manufacturing
• Travel on an intermittent basis is required (approximately 5-10%) to support job responsibilities and commitments.

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Job Title: Maintenance Specialist

Reports to: Director, Supply Chain & Facilities

Role Description:

We are currently seeking a Maintenance Specialist to join the Forge Biologics team. This is an exciting opportunity to drive the startup efforts by supporting general maintenance efforts as it relates to HVAC and electrical infrastructure. This role will assist with installing, maintaining, and repairing electrical wiring, equipment, and fixtures and ensure that work is in accordance with relevant codes. Candidate will install or service lighting, electrical generation or other electrical control systems at our Columbus, Ohio facility, as well as review and assist as a Subject Matter Expert (SME) on vendor selection and contract completion.

Responsibilities:

• Directs, trains, and/or individually installs, maintains, or repairs electrical wiring, equipment, or fixtures related to facility operation
• General Plant Maintenance (Mechanical, Structural, Electrical)
• Performs business management duties, such as maintaining records or files, preparing reports, or ordering supplies or equipment
• Plans, lays out, and installs electrical wiring, equipment, or fixtures, based on job specifications and local codes
• Tests and inspects electrical systems or continuity of circuits in electrical wiring, equipment, or fixtures, using testing devices, such as ohmmeters, voltmeters, or oscilloscopes, to ensure compatibility and safety of system
• Uses a variety of tools or equipment, such as power construction equipment, measuring devices, power tools, and testing equipment, such as oscilloscopes, ammeters, or test lamps
• Prepares sketches or follows blueprints to determine the location of wiring or equipment and to ensure conformance to building and safety codes
• Diagnoses malfunctioning systems, apparatus, or components, using test equipment and hand tools to locate the cause of a breakdown and correct the problem
• Advises management on whether continued operation of equipment could be hazardous
• Constructs or fabricates parts, using hand tools, according to specifications
• Supports all operational conditions across the site to assure seamless operation of the facility on a 24/7/365 basis as required
• Gowns as required to enter confined spaces and controlled cGMP environments to assure facility operations

Requirements:

• High School diploma or equivalent
• Certifications in relevant field such as Electrical or HVAC
• Minimum of 8 years’ experience in maintenance and support roles
• Must be self-motivating, organized and proactive
• Strong technical aptitude including demonstrated experience in applying scientific reasoning to solve complex problems.
• Ability to work hours necessary to support production and/or product transfer activities.
• English Language - Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
• Clerical - Knowledge of administrative and clerical procedures and systems such as word processing, managing files and records, designing forms, and other office procedures and terminology.

Reporting Outline:

• This position reports to the Director of Supply Chain & Facilities
• Travel on an infrequent basis is required (<5%) to support job responsibilities and commitments.

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Job Title: Director, cGMP Manufacturing Operations

Reports to: Chief Operating Officer (COO)

We are currently seeking a Director of cGMP Manufacturing Operations to join the Forge Biologics team. In this role, the Director of Manufacturing actively contributes to the strategic, operational, and production activities required to support the cGMP manufacturing programs and vision. The Director manages the cGMP assets and personnel in the operations department for both internal and external gene therapy programs.

This is an exciting opportunity to provide leadership and oversight of the required services and systems to make our organization successful. The candidate will lead a team of managers, scientists, analysts, and technicians to work with vendors, internal users, and external clients to support GMP and business operations. The candidate will serve to assure all groups are properly supported and integrated into new systems and communications to support future growth and the Forge strategic vision.

The Director will have oversite of the upstream and downstream manufacturing teams and will be responsible for coordination of these teams in synergy with all internal groups to assure schedule attainment for our internal and external clients. The Director will play a crucial role in developing and maintaining these teams and will be the local subject matter expert for all regulatory inspections for all manufacturing related activities. Additionally, the candidate will lead/participate in addressing Regulatory Agency responses resulting from CTA/IND and BLA/MAA applications.

The Director will take part in coordinating and participating in construction efforts for continued growth of the facility as well as the continued support of the facility moving forward. The individual chosen for this position will work in close partnership with all branches of the Forge leadership team, and/or external parties to support GMP manufacturing. The focus of this management role is to employ learned approaches to ensure Forge provides and maintains a state of the art AAV facility for pre-clinical, clinical, and commercial viral vector products, working in close partnership with internal and external experts to realize this goal.

The Director will also have a prominent role in working with new clients and the business development team at Forge Biologics. Strategic vision and collaborative partnerships are required for Forge to be successful as we execute our phased build plan.

To this end, the Director of cGMP Manufacturing Operations will keep current on new technologies, and regulatory requirements that may have an impact on the company’s development, while ensuring adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Role Description:

• Provides strategic and operational management of manufacturing department responsible for producing viral vector/gene therapy products.
• Accountable for ensuring adherence to strict regulatory requirements to ensure product quality.
• Works with the all internal teams at Forge and across the GMP Operations team to ensure effective communication between all groups.
• Assists and coordinates review of all manufacturing protocols, reports, records, procedures, and batch documentation to assure compliance and completeness.
• Provides management for and ensures the effective transfer of manufacturing methods to and from external groups in a phase-appropriate fashion, to support pre-clinical, clinical, and commercial activities.
• Participates in the hiring, training and leadership of the Manufacturing Operations team
• Ensures a science-driven, phase appropriate, and risk-based manufacturing strategy to support development projects from clinical to commercial manufacture for internal therapeutic programs.
• Ensures adherence to timelines in support of IND, BLA, and all relevant ex-US regulatory filings.
• Manages and mentors staff to build a highly functional operations team that may be cross-trained in multiple areas, as needed.
• Builds the scientific knowledge, capabilities, and strategies in gene therapy manufacturing group that enables high paced product development and commercialization.
• Works directly with Senior Leadership to assure process communications are occurring in a timely manner and budget and timelines are being adhered to.
• Operates as the Subject matter expert (SME) that participates in the engineering effort to assure manufacturing equipment and supporting materials are in place that meet current GMP requirements from design through procurement, installation and operational readiness, and contains associated required documentation.
• Supports business development activities including vendor and contractor selection as well as resource and response generation for bids and project budgeting.
• Supports future business evolution through process knowledge expansion and supporting internal product and process development activities.

Requirements:

PhD in biology, virology, chemistry, or related discipline and a minimum of 10 years of experience in biologics and/or gene therapy manufacturing roles, OR Master’s degree in these same disciplines or business and a minimum of 12 years of relevant experience, OR Bachelor’s degree in these same disciplines or business and a minimum of 15 years of relevant experience.

Special Knowledge or Skills Required:

• Comprehensive experience with the GMP manufacturing techniques and regulatory requirements for cell and gene therapy products.
• Expert level knowledge of CMC analytical and validation requirements.
• Expert level knowledge of mammalian cell culture.
• Expert level knowledge of aseptic processing and technique.
• Prior experience with commercial manufacturing within CROs/CMOs.
• Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports.
• Excellent oral and written communication skills.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Ability to work hours necessary to support production and/or product transfer activities.
• Ability to present to and interact with Senior Leadership.

Special Knowledge or Skills Preferred.

• Minimum of 10+ years’ experience in leadership/management/supervision with a preference toward direct Gene Therapy/Cell Therapy industry experience.
• Small company and/or start-up experience.
• Experience in high-level interactions with domestic and international Regulatory agencies.
• Travel requirements: 0 to 15%

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Job Title: Clinical Trial Manager

Position Description

We are currently seeking a Clinical Trial Manager (CTM) to join the Forge Biologics team. The CTM will be an integral part of the Clinical Development team by managing clinical trials through launch, execution and close out. The CTM will report directly to the Director, Clinical Program Management and will also work with the Regulatory Affairs, Patient Advocacy/Community Engagement and Product Development teams to ensure that clinical trials are conducted in a timely fashion and in compliance with SOPs, ICH/GCP/regulatory guidelines, company goals, and budgets. Key attributes for the role include experience with gene therapy and rare diseases, ability to work independently, and to efficiently perform multiple tasks and manage changing priorities.

Key Responsibilities:

• Support development of study-related documents including site feasibility, informed consent documents, monitoring plans, regulatory and start-up plans, patient recruitment plans, pharmacy and lab manuals and training materials.
• Works with study team to design clinical trial protocol and assists in developing/managing ongoing data review to ensure detection of data trends and to ensure study objectives are met
• Tracks the progress of the clinical trial including patient recruitment, trial supplies and trial documentation through dedicated study tools
• Oversee the Trial Master File (TMF) and conduct periodic reviews for completeness
• Participates in selection and management/oversight of external vendors; reviews vendor reports, budgets, and metrics
• Provides study-specific training and leadership to clinical research staff, including CRO, CRAs, sites and other contract personnel
• Leads study-specific meetings including regular internal updates, site operations, safety review and CRO oversight
• Leads DSMB meetings, including preparation of pre-meeting reports and post-meeting minutes in collaboration with the CRO
• Manages clinical monitoring activities including approval of visit report templates, monitoring plans, ensuring compliance with ICH/GCP and applicable regulations; participates in site monitoring visits as appropriate
• Support patient enrollment efforts and help ensure data collection are completed in accordance with study timelines and objectives
• Responsible for tracking study budgets, including invoice and PO management/reconciliation, month end actuals and accruals.
• Manages clinical monitoring activities including approval of visit report templates, monitoring plans, ensuring compliance with ICH/GCP and applicable regulations
• Work collaboratively with supply chain to ensure seamless collection/manufacture/shipment of clinical trial material
• Ensures all clinical trials are executed in compliance with ICH/GCP guidelines/regulations and applicable SOPs; ensure audit-ready conditions of clinical trial documentation including central clinical files; reviews monitoring reports to ensure quality and resolution of site-related issues; coordinates and assists in the planning of regulatory or ethics committee activities, as appropriate
• Identify issues, recommend and follow up on corrective actions to ensure quick resolution of deviations or quality issues
• Manage external relationships critical to the success of clinical programs including investigational sites, key opinion leaders and other external partners
• Actively participate in department initiatives; contributes ideas on department initiatives and goals that will make a difference to the efficiency and effectiveness of Clinical Development.
• Travel on an infrequent basis is required (<10%) to support job responsibilities and commitments

The successful candidate has:

• Bachelor’s degree
• 5+ years of direct experience in clinical trial execution
• Knowledge of GCPs, ICH guidelines and FDA regulations.
• Experience with rare disease clinical trial management
• Experience with gene therapy clinical trials
• Excellent communication (verbal and written), organizational and problem-solving skills
• Experience developing and managing clinical trial budgets
• Experience managing external contract research relationships
• Proficient in the use of the Microsoft Office suite of products, including Word, Excel, PowerPoint and Outlook
• Excellent interpersonal skills and the ability to work well in small teams and with a wide range of varying stakeholders
• Ability to be flexible and adaptable in the face of changing organizational priorities and ambiguous environments

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Job Title: Manager, Research Manufacturing

Reports to: Chief Technical Officer

Role Description:

We are currently seeking a Manager of Research Manufacturing to join the Forge Biologics team. This is an exciting opportunity to provide active leadership and oversight of upstream and downstream  vector  production.  The  candidate  will  lead  a  team  of  skilled  technicians  and scientists to produce research and toxicology grade rAAV vectors. The ideal candidate will be an expert in technical problem- solving, laboratory techniques, and developing interorganizational relationships to support our growth in the Gene Therapy sector.

This position is responsible for overseeing production of research-grade recombinant adeno- associated virus (rAAV) vectors in mammalian and insect cell lines. The incumbent will offer hands-on leadership of the production group utilizing shake flasks and single-use bioreactors for upstream work, and FPLC systems, tangential flow filtration, centrifugation, and other downstream purification technologies. Work activities will also include scheduling, equipment management, preparing protocols and study reports related to production work with minimal supervision. The Manager will review relevant literature, data of team scientists and associates, and ensure that all staff are properly trained.    It is expected that the incumbent will work independently while accomplishing the timely completion of assignments and necessary resolution of unexpected technical issues.

The individual chosen for this position will work in close partnership with manufacturing leadership, and external parties to support manufacturing of vector candidates. The Manager will also  work  closely  with  the  Directors  of  Process  and  Analytical  Development  to  facilitate seamless movement of projects through the development continuum. The focus of this leadership role is to employ novel approaches to ensure Forge provides and maintains a state-of-the-art rAAV manufacturing platform process for viral vector products, working in close partnership with internal and external experts to realize this goal.

To this end, the Manager of Research Manufacturing will keep current on new technologies, and regulatory requirements that may have an impact on the company’s development and manufacturing plans.

Responsibilities:

• Schedule and adhere to daily, weekly, and monthly production targets for internal and external clients
• Organize workflow and clearly communicate duties and tasks to direct reports
• Participate,  oversee,  and  communicate  priorities  for  the  execution  of  upstream  and downstream manufacturing procedures for simultaneous batches
• Maintaining cell growth, transfection, and infection of mammalian and insect cells for baculovirus and rAAV manufacturing using shake flasks and single-use bioreactors
• Execution  of  downstream  purification  technologies  related  to  rAAV  purification  using chromatography (affinity and ion-exchange) and filtration processes including microfiltration, depth filtration, tangential flow filtration, and sterile filtration
• Assist in the production of preclinical and toxicology materials in a laboratory setting
• Perform vector characterization assays (qPCR, SDS-PAGE, Western blotting, etc.) on in- process and final samples on as needed basis
• Preparing protocols and reports in notebooks and electronic documents
• Train junior staff in the various upstream, downstream, and analytical techniques
• Oversee inventory management for the group in coordination with materials management group to keep lab well stocked and organized
• Track production and quality metrics
• Interface with other departments (Analytical Development, Process Development, Program teams, etc.) as necessary
• Communicate production schedule and vector data to management, program managers, and clients
• Ensure  that  operations  adhere  to  the  plant  schedule  and  critical  activities  are  always performed within the allotted timeframes
• Support  business  development  activities  including  vendor  and  contract  manufacturer selection as well as resource and response generation for bids and project budgeting
• Support future business evolution through process knowledge expansion and supporting internal product and process development activities
• Additional responsibilities not listed may be assigned as needed by leadership.

Requirements:

• Bachelor’s degree with 8+ years’ relevant experience; or Master’s degree with 6+ years’ direct experience, or Ph.D. with the completion of a postdoctoral fellowship in biological sciences or two years’ of relevant experience in biopharmaceutical manufacturing/R&D
• Technical proficiency required for aspects of production of biological products
• Experience in production of viral vectors is preferred
• Broad knowledge of cell culture techniques is required; experience with bioreactors is preferred
• Working knowledge of downstream purification techniques; experience with GE AKTA systems (Pure, Avant, or Pilot) or Bio-Rad NGC FPLC systems is highly preferred
• Experience with production of biologics and performing bioassays is preferred
• Previous experience in training and oversight of direct reports is required
• Experience working in a cGMP environment is preferred
• Must be self-motivating, organized and proactive
• Strong technical aptitude including demonstrated experience in applying scientific reasoning to solve complex problems
• Ability to work hours necessary to support production and/or product transfer activities
• Ability to work in loud noise environments and in Personal Protective Equipment (PPE) and cleanroom gowning attire as needed

Reporting Outline:

• This position reports to the CTO
• Travel  on  an  intermittent  basis  is  required  (approximately  5-10%)  to  support  job responsibilities and commitments

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Job Title: Senior Scientist, Process Development

Reports to: Director, Process Development

Role Description:

We are currently seeking a Senior Scientist to join the Forge Biologics team. This is an exciting opportunity to lead efforts and characterize bioprocess methods to support viral vector manufacturing. The candidate will lead downstream biomanufacturing development and support upstream development in the manufacturing of viral vector for clients at various scales ranging from 500mL to 500L. The ideal candidate will be highly skilled in technical problem-solving and bioprocessing techniques to support our growth in the Gene Therapy sector.

This position reports to the Director of Process Development and is responsible leading downstream process development activities for production of recombinant adeno-associated virus (rAAV) vectors. You will oversee and perform scalable downstream purification technologies for rAAV using depth filtration, FPLC systems, tangential flow filtration, and centrifugation. Work activities will also include compiling experimental data, writing protocols and study reports, and presenting findings to internal and external parties with minimal supervision. It is expected that you will lead and participate as part of the process development team while accomplishing the timely completion of assignments and reporting of unexpected technical issues.

Responsibilities:

• Independently design, execute, and analyze experiments optimizing production and purification of AAV
• Directly supervise the downstream activities of the Process Development Lab – manage experiments, equipment, inventory, and workloads
• Compile and review experimental data with minimal oversight and author publications, protocols, or reports
• Support large-scale manufacturing runs and ensure timely delivery of materials to internal and external partners
• Delivering results in a high paced environment
• Train and mentor junior laboratory technicians
• Additional responsibilities not listed may be assigned as needed by leadership

Requirements:

• Master’s Degree or higher in Chemistry, Chemical Engineering, Biochemistry, Biotechnology, or related and 8+ years’ experience, or PhD degree preferred, with 2+ years’ experience
• Practical experience with FPLC is a must, ideally at both Lab and Pilot scales
• Experience with other aspects of downstream purification (e.g. – clarification/filtration, TFF, etc.) is required
• Experience with suspension cell culture at all scales: flasks, bench-top bioreactors, and large-scale single-use bioreactors is preferred
• Experience with purification of vaccines or viral vectors is preferred
• Proficiency with MS Excel, GraphPad Prism, and electronic lab notebooks is essential
• Proficiency designing, executing, and analyzing DOE is highly desired
• Must be self-motivating, organized and proactive
• Strong technical aptitude including demonstrated experience in applying scientific reasoning to solve complex problems
• Must have excellent verbal and written communication skills
• Must have demonstrated experience effectively managing multiple projects and staff
• Ability to work hours necessary to support development and/or product transfer activities.
• Must be able to work independently, but is also a team player with strong collaborative skills

Reporting Outline:

• This position reports to the Director of Process Development
• Travel on an intermittent basis is required (approximately 5-10%) to support job responsibilities and commitments.

Apply

Job Title: Research Associate, Analytical Development

Job Description:

As a member of the Analytical Development group this position will help drive the development of Forge Biologic’s in-house programs as well as client programs. You will be responsible for the development of molecular assays including, but not limited to, qPCR, Sanger sequencing, NGS, ELISAs, protein and DNA gel electrophoresis, and cell-based and immunoassays supporting the gene therapy analytical development organization. This position is also responsible for clear and timely documentation of assay results and communicating data to supervisor. This role supports adherence to all regulatory requirements and company Standard Operating Procedures (SOPs).

Primary Responsibilities Include:

• Performing product characterization related assays in support of release and characterization, method development/optimization, methods transfer, and analytical support for gene therapy product process development and manufacturing. These include, but may not be limited to DNA/RNA isolation, qPCR, RT-qPCR, ddPCR, ELISA, SDS-PAGE and Western Blot
• Compiling experimental data with minimal oversight, generating reports, and archiving assay data.
• Assist the gene therapy process development team in the analysis and interpretation of assay results.
• Support the analytical and process development group's daily operational needs by maintaining assay cell lines, controls, standards, and reagent inventories.
• Apply relevant scientific principles and techniques to analytical development problems.
• Maintain detailed, up to date, and reviewed laboratory notebooks.

Education and Skills Requirements:

• A Bachelor’s degree in biology, molecular biology, virology, biochemistry or related discipline and a minimum of 4 years of relevant experience in a pharmaceutical, biotechnology or related environment or a Master’s degree in these same disciplines and a minimum of 2 years of relevant experience in these same environments
• Proficiency with the conduct of qPCR, cell-based assays, and immunoassays is preferred
• Experience in CMC analytical and regulatory requirements, including development of product specifications and extended analytical characterization is preferred
• Proficiency with Microsoft Office
• Excellent verbal and written communication skills
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members
• Ability to work with a high attention to detail
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects at various stages of development

Apply

Job Title: Scientist, Analytical Development

Job Description:

As a member of the Analytical Development group this position will help drive the development of Forge Biologic’s in-house programs as well as client projects. You will be responsible for the design and optimization of molecular assays including, but not limited to, qPCR, Sanger sequencing, NGS, ELISAs, protein and DNA gel electrophoresis, and cell-based and immunoassays for evaluation of final and in- processes for gene therapy vectors. This position is also responsible for clear and timely documentation of assay results and communicating data to supervisor, as well as reviewing the data of junior team members. This role supports adherence to all regulatory requirements and company Standard Operating Procedures (SOPs) .

Primary Responsibilities Include:

• Design and execute cell culture experiments and bioanalytical assays to support manufacturing, purification and clinical comparability of AAV gene therapy products
• Design, optimize and perform analytical assays such as DNA/RNA isolation, qPCR, RT-qPCR, ddPCR, ELISA, SDS-PAGE and Western Blot
• Perform AAV infectivity titration and neutralization assays
• Work seamlessly with cross functional stakeholders including Process Development, Product Development, and Quality Control to help advance the AAV vector production portfolios
• Participate in project related teams and other internal/external collaborations
• Maintain clean and fully functional laboratory and adhere to all laboratory standards as defined in SOPs
• Ensure that scientific and technical challenges are resolved in a timely manner
• Contribute to a safe, efficient, and effective environment with personal accountability

Education and Skills Requirements:

• PhD in Molecular Biology, Biotechnology, Biochemistry, Immunology, Virology, or a related field with 0-2+ of relevant experience, or MS with 6+ years of related experience in assay development
• Experience with aseptic techniques in mammalian cell culture systems and performing bioassays
• Technical proficiency in quantitative PCR
• Experience in gene therapy and/or vaccine testing is preferred
• Prior experience performing viral genome titer, infectivity, potency, host cell protein, and host cell DNA assays is preferred
• Experience with ddPCR, ELISA, SDS-PAGE and Western Blot is preferred
• Knowledge of analytical ultracentrifugation techniques is desirable
• Excellent written and verbal communication skills
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members
• Ability to work with a high attention to detail with minimal supervision
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects at various stages of development
• Proven record of successfully planning experiments and executing projects in collaboration with internal or external stakeholders

Apply

Job Title: GMP Associate (multiple positions)

Reports to: Director GMP manufacturing Operations

Role Description:

We are currently seeking a GMP Associate to join the Forge Biologics team. This is an exciting opportunity to contribute to and lead efforts in the execution of manufacturing life changing gene therapies for human use. The candidate will participate in GMP manufacturing campaigns and provide hands-on support for new technologies and systems in our GMP manufacturing facility. The ideal candidate will be skilled in technical problem-solving and laboratory techniques to support our growth in the Gene Therapy sector.

The GMP Associate provides manufacturing and operational expertise for the Forge GMP facility in Grove City, OH. This will include technical writing, routine testing, and all other associated activities. The GMP Associate responsibilities include, but are not limited to; training, sampling, manufacturing activities, method qualification/validations, investigations, and cleaning support. Additional responsibilities include adherence to all GMP requirements, a basic understanding of FDA/EMEA regulations, and effective interactions/communication with Operations Management. The GMP Associate may also support the Operations management team for activities related to interviewing and training of employees, compliance with GMP, and identifying and implementing corrective and preventive actions.

Prior experience/specialized skills may result in additional responsibilities and/or development opportunities. The GMP Associate may be responsible for performing the manufacturing and in- process sampling for our most advanced AAV-based (viral vector) therapeutic candidates generated from the PD, research, and GMP laboratories. The GMP Associate will execute the procedures designed to assure safety, efficacy, and purity of the drug products being manufactured. The GMP Associate may be responsible for upstream (cell culture and virus production) and/or downstream (harvest and purification) manufacturing activities to support a processes for the entire AAV program portfolio.

Responsibilities:

• Performs manufacturing activities and sampling that incorporates application of GMP principles and methodologies.
• Supports thorough investigations to determine root cause of OOS investigations the implementation of appropriate corrective and preventative actions in a timely manner.
• Trains junior staff in laboratory skills and scheduling lab/equipment.
• Plans work to meet production and schedule requirements from clients (internal and external).
• Prepares data associated with manufacturing processes and transfer activities to clients. May serve as the Person-in-Plant (PIP) support during manufacturing campaigns.
• Supports internal process transfer activities and may serve as Subject Matter Expert (SME) to troubleshoot processes.
• Delivers results in a high paced environment.
• Supports packaging and shipping finished product and/or coordinates the effort.
• Additional responsibilities not listed may be assigned as needed by management.

Requirements:

• Minimum Bachelor’s Degree (B.A. or B.S.) in scientific-related field or engineering (or equivalent work experience).
• Minimum 1-2 years’ experience in a GMP or QC environment strongly preferred.
• Must be self-motivating, organized, and proactive.
• Strong technical aptitude, including demonstrated experience in applying scientific reasoning to solve complex problems.
• Ability to work hours necessary to support production and/or product transfer activities.
• Ability to work in confined spaces and near operating equipment.
• Ability to work in loud noise environments and in Personal Protective Equipment (PPE) and Clean Room gowning attire as needed.
• Travel on an infrequent basis is required (<5%) to support job responsibilities and commitments.

Special Knowledge or Skills Preferred:

• Detailed/Demonstrated knowledge and understanding of GMP regulations and Food and Drug Administration (FDA) requirements.
• Working knowledge of global pharmacopeias such as USP, EP, JP, BP, Ph. Eur.
• Knowledge of biopharmaceutical manufacturing process workflows.
• Knowledge in the following system(s): Cell Culture and Cell-based assays, Pharmaceutical Utilities, HPLC, Microbial testing, Mass spectrometry, AUC, PCR, ELISA, and gel electrophoresis.

Apply

Job Title: Manager, Regulatory Affairs-CMC

Reports to: VP, Regulatory Affairs

Role Description:

Forge Biologics, Inc. seeks an experienced Regulatory Affairs Manager to join our growing team. This role will be accountable for the preparation and management of CMC (chemistry, manufacturing, and control) components for dossiers and submissions of Module 2.3 and Module 3 CTD (common technical document) sections, Drug Master Files (DMFs), Site Master Files (SMFs) and related progress reports, amendments, supplemental applications. This includes continued maintenance of these CMC regulatory submissions to the FDA, EMA and other global regulatory agencies. This role works across functional groups and directly with external client teams to propose strategies and solutions. Responsibilities include coordination and management of CMC change control and related databases for clinical and commercial applications. The position will support compliance with regulatory authority regulations and interpretations with opportunities to interact with global regulatory agency personnel.

A strong candidate will demonstrate independent project management, document creation and lead the integration of regulatory filings with various teams including operations, quality, external clients, and external CROs and consultants in the planning, organization, and preparation of regulatory documents. Excellent written and effective verbal communication skills along with flexibility and ability to work in a fast-paced environment are a must.

Responsibilities:

• Assist in the technical review and preparation of various investigational drug, marketing applications and other formal reports for submission to regulatory agencies
• Ensure that the content and structure of documents meet established regulatory requirements.
• Actively contribute to the development and implementation of regulatory strategy for assigned projects.
• Liaise as CMC representative across functional groups, client teams, international regulatory groups and business partners, propose strategies and solutions at level of personal technical experience and identify issues that may delay project timelines.
• Provide support for other members of the department on the basis of workload.
• Prepare, coordinate, manage or maintain regulatory CMC documentation submissions (e.g., Module 2.3 & Module 3 CTDs, DMFs, amendments, annual reports, meeting packages, etc.) in accordance with applicable regulations; this includes ability to translate regulatory requirements into practical, workable submission plans; develop & maintain timelines; coordinate internal/external authoring/review/comment adjudication and finalization (submission and archival).
• Provide thoughtful & accurate comments during document development and review, aware of regulatory/USP/ISO/ICH guidance/requirements pertaining to document content.
• Interface with external regulatory groups (e.g., CRO, partners, consultants, etc.) in the preparation/review/compilation/finalization/submission/posting of regulatory submissions.
• Review and communicate current & emerging regulatory requirements (e.g., US and international regulations and guidelines).
• Author and review standard operating procedures (SOPs); provide review that SOPs are in compliance with current regulatory requirements and support for corporate quality assurance efforts.
• Develop and maintain current regulatory knowledge.
• Coordinate with external API and critical material supply partners to manage regulatory submissions.
• Participate and support client quality audits and regulatory and health authority site inspections and pre-approval inspections of manufacturing facility and supporting systems.

The Ideal Candidate:

• Bachelor’s degree in a scientific discipline or equivalent. Advanced degree or Regulatory Affairs Certification is preferred.
• Candidate must have at least 3 to 7 years of Regulatory experience in the pharmaceutical or biotechnology industry, with demonstrated increasing expertise and responsibility.
• Prior experience in providing client-based external consultation is preferred.
• Must have experience independently preparing and submitting documents in an eCTD compliant manner and assigning STFs.
• Must have a solid understanding of FDA regulations and ICH guidance, as well as a comprehension of the drug development process.
• Experience with regulatory submissions in Common Technical Document format is essential.
• Able to handle multiple projects and exercise good judgment in prioritizing tasks.
• Demonstrated ability to work independently and within a group setting, and to interact effectively with various functional groups.
• Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.
• High level of attention to detail, and be proficient with Microsoft Office applications, Adobe, Sharepoint, and document management templates. Experience with eCTD publishing software is preferred.

Reporting Outline:

• This position reports to VP of Regulatory Affairs
• Travel on an intermittent basis is required (approximately 10-20%) to support job responsibilities and commitments.

Apply

Job Title: Technical Writer

Reports to: Director, Supply Chain & Facilities

Role Description:

We are currently seeking a Technical Writer to join the Forge Biologics team. This is an exciting opportunity to drive the startup efforts by authoring, reviewing and processing documents needed for our Columbus, Ohio operations. The candidate will collaborate with site Subject Matter Experts (SMEs) in order to transcribe process, procedure and work instructions into usable documents that will support our Quality Management System and adhere to cGMP principles. The ideal candidate will be skilled in technical writing, understand and learn new processes quickly, as well as write and translate various subject matters clearly and in a concise manner that will support our employee training efforts.

The Technical Writer is responsible for authoring documents in support of all current departments at the Columbus facility. These areas include Safety, Quality, Training, Regulatory, Maintenance, Development, Operations, and Validation efforts. The Technical Writer will also support all new documents that may be deemed necessary as business requires. This role reports to the Director of Supply Chain & Facilities. The Technical Writer will be responsible for supporting Process, Product, and Analytical Development, as well as any cGMP/Commercial processes.

Responsibilities:

• Writes, edits, and reviews cGMP manufacturing documents, validation protocols, SOPs, and development related material in support of Development, Analytical, and Operations activities, while maintaining standardized and consistent documentation practices for recording details of new processes for the manufacture of biopharmaceutical products.
• Organizes material according to set standards regarding order, clarity, conciseness, style, and terminology.
• Edits, standardizes, or suggests changes to material prepared by other writers or Forge personnel to verify accuracy, consistency, grammar, and format.
• Maintains records and files of work and revisions.
• Collaborates with Development and Operations personnel to become familiar with product technologies and production methods.
• Observes production, developmental, and experimental activities to determine operating procedure and detail.
• Selects photographs, drawings, sketches, diagrams, and charts to illustrate material.
• Studies drawings, specifications, mockups, and product samples to integrate and delineate technology, operating procedure, and production sequence and detail.
• Reviews manufacturer's manuals and trade catalogs, drawings and other data relative to operation, maintenance, and service of equipment.
• Confers with customer representatives, vendors, facility executives, or publishers to establish technical specifications and to determine subject material to be developed.

Requirements:

• Bachelor’s Degree, preferably in a Life Sciences or Engineering field (or equivalent work experience and education).
• Minimum of 2 years of experience in technical writing with a biopharmaceutical manufacturing, validation, or quality control background (preferably in a cGMP setting).
• Must be self-motivating, organized, and proactive, with a strong attention to detail Strong technical aptitude including demonstrated experience in applying scientific reasoning to solve complex problems.
• Demonstrated experience with Standard Operating Procedures, Protocols, and Reports.
• Ability to work hours necessary to support production and/or product transfer activities.
• Intermediate to advanced computer software skills including Microsoft Office, database and spreadsheet creation and maintenance, filing, organization, record keeping and planning skills, multiple projects, time management
• Knowledgeable in FDA GMPs (21 CFRs 210, 211, and/or 600) a plus.

Reporting Outline:

• This position reports to the Director of Supply Chain & Facilities
• Travel on an infrequent basis is required (<5%) to support job responsibilities and commitments.

Apply

Job Title: Human Resources Director

Reports to: Vice President of Finance and Operations

Role Description:

We are currently seeking a Human Resources Director join the Forge Biologics team. This is an exciting opportunity to join a high growth gene therapy manufacturing company and to lead the development and implementation of people-related services, policies, and programs. The Human Resource Director will plan, lead, direct, develop, and coordinate the policies, activities, and staff of the Human Resource (HR) department, ensuring compliance and implementation of the organizations mission and talent strategy. The candidate will work directly with the Vice President of Finance and Operations as well as having direct exposure to the executive leadership team. The ideal candidate will have led Human Resources in practice and helped set objectives that will provide an employee-oriented, high-performance culture that emphasizes empowerment, quality, productivity, standards and goal attainment. This position requires someone who readily adapts to change and is comfortable with setting up HR structure in a high growth startup environment.

Responsibilities:

• Be a trusted advisor and partner to leaders in identifying and building talent strategies within teams and across the company.
• Contribute in developing programs and systems for a healthy organization.
• Collaborate with cross functional partners to plan, lead, develop, and implement policies, processes, training and initiatives to support the organizations human resources strategy and compliance needs.
• Develop and buildout consistent and seamless onboarding procedures for new employees.
• Provide professional human resource coordination in a variety of areas to include training, safety, employee relations, benefits review and enrollment, compensation, unemployment and worker’s compensation.
• Develops and delivers initiatives that help to reinforce culture that enables top talent to feel engaged, contribute, grow in their career and develop leadership skills.
• Propose and lead HR initiatives, policies and programs including resolution of employee issues and conflicts.
• Ensure the organization’s compliance with local, state, and federal regulations.
• Counsel employees regarding benefit issues, eligibility for insurance, and coverage.
• Develop and implement a department budget, as needed.
• High degree of professionalism and confidentiality
• Performs other duties as required.

Requirements and Qualifications:

• 10+ years of progressive human resources experience.
• Ability to create and implement sustainable HR solutions.
• Advanced knowledge of HR policies, practices and employment law.
• Experience in employee relations, performance management, and workplace accommodations a plus.
• Experience with ADP WorkforceNow and Greenhouse a plus.
• Possesses strong program management skills along with effective verbal and written communication skills.
• Ability to coach and influence at any level withi the organization.
• Excellent organizational skills and attention to detail.
• Ability to adapt to the needs of the organization and it’s employees.
• Bachelor’s degree in HR or related field

Apply

Job Title: Manager, Investor Relations

Reports to: Vice President, Finance and Investor Relations

Role Description:

We are currently seeking a Manager of Investor Relations to join the Forge Biologics team. This is an exciting opportunity to join a high growth gene therapy manufacturing and therapeutics development company. The candidate will work directly with the Vice President of Finance and Investor Relations as well as having direct exposure to the executive leadership team. The ideal candidate will provide support of all investor relations activities in order to increase shareholder exposure to the company by effectively communicating company strategy, goals, business plans, and results. This position requires someone who readily adapts to change and is comfortable with setting up Investor Relations structure in a high growth environment.

Responsibilities:

• Collaborate with the VP Finance/IR and Executive team members to assist/lead the creation of value-driver-based investment messages.
• Monitor and report on market intelligence by tracking research reports, news, earnings results and material from other relevant sources
• Develop detailed knowledge of value drivers for the company
• Collaborate with the investor relations team to prepare quarterly board forecasts and budget updates, and investor selection/identification strategies
• Support the design and execution of institutional investor targeting by supporting construction and execution of investor days, conferences, and analyst meetings and calls.
• Monitor inbound investor inquiries and deliver efficient and responsive resolution to investor requests
• Travel up to 30%

Requirements and Qualifications:

• 4+ years in areas of equity research, investment banking, corporate finance or investor relations consulting
• Bachelor’s Degree in finance or related field
• A clear and thorough understanding of the financial modeling techniques used by security analysts to project a company’s operating and financial performance.
• A good understanding of securities regulations and strategic communication
• Ability to adhere to company policies and federal regulations regarding information disclosure
• The preferred candidate will have experience with institutional financing and developed bank relationships

Apply

Job Title: Quality Engineer

Reports to: Sr. Manager, Quality Engineering

Role Description:

We are currently seeking a Quality Engineer (QE) to join the Forge Biologics team. The QE will work as part of a cross functional team providing quality oversight, review, and approval of engineering, validation, and change control deliverables to ensure that products and processes meet the appropriate regulatory agency requirements, internal company standards, and current industry best practices.

The QE actively contributes to the strategic and operational activities for both internal and external gene therapy programs. This includes, but may not be limited to, commissioning qualification of GMP manufacturing and laboratory equipment, facilities, utilities, computerized systems, aseptic process simulations, and process validation.

This is an exciting opportunity to provide technical expertise and oversight of the required support services and systems to make our organization successful. The candidate will work with vendors, internal users, and external clients to support GMP and business operations. The candidate will provide technical and quality direction to all groups and support future growth and the Forge strategic vision.

Working in a matrix management environment that includes Analytical Development, Process Development, Clinical and Commercial Manufacturing, Quality Assurance, Quality Control, Validation Operations, Regulatory Affairs, and Supply Chain, the candidate will be responsible for maintaining a detailed understanding of the status of each program to prioritize and effectively execute on QE-related activities.

The Quality Engineer will take part in coordinating and participating in construction efforts for the phased build out of the facility as well as the continued support of the facility moving forward. The individual chosen for this position will work in close partnership with all Operations leadership, and/or external parties to support GMP manufacturing of clinical drugs. The focus of this role is to employ site approaches to ensure Forge provides and maintains a state of the art AAV facility for pre-clinical, clinical, and commercial viral vector products, working in close partnership with internal and external experts to realize this goal.

To this end, the QE will keep current on new technologies and regulatory requirements that may have an impact on the company’s development, while ensuring adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Responsibilities:

• Provides operational implementation of Quality Engineering standards for proper system design, technology transfer, and change control documentation, including providing quality risk assessments (e.g., FMEA, Design Reviews, and Impact Assessments).
• Ensure required SOPs and systems are followed to support internal and external validation programs.
• Provides support for and ensures the effective technical transfer of processes to Operations/Manufacturing in a phase-appropriate fashion, to support pre-clinical, clinical, and commercial activities.
• Review and approval of Validation documentation for equipment, facility, and utility (EFU) used in the manufacture of GMP cell banks and sterile drug product. Examples of equipment includes biological safety cabinets (BSCs) bioreactors, chromatography systems, and controlled temperature units (CTUs).
• Review and approval of Validation documentation including, Impact Assessments, User Requirements Specifications, Design Qualifications, Test Protocols (IQ/OQ/PQ), Reports, Process Performance Qualification, Aseptic Process Simulations (media fills), Cleaning Verification/Validation studies, and other miscellaneous commissioning, qualification, and validation activities.
• Supports Computerized System Validation (CSV) to ensure compliance to 21 CFR Part 11 and applicable FDA Guidance on data integrity.
• Support review and continued maintenance of site SOPs and project related documents.
• Provide Quality support of the Preventative Maintenance and Calibration Program, including review and approval of procedures, completed PMs and calibrations, and compliance to the PM and calibration schedules. Review out of tolerances (OOT) and support investigations assessing product impact.
• Support investigations and provide technical support and assessment of system, product and process impact.
• Report validation/qualification quality issues and trends to Senior Management.
• Support external audits performed by regulatory/inspection agencies or clients and audit/inspection readiness activities.
• Provides input to project timelines, scheduled activities, and status updates.

Requirements:

• Bachelor’s degree in Science or Engineering or related discipline with 5+ years of experience, with a minimum of 3+ years validation experience within an FDA regulated pharmaceutical, biotech, or related industry/manufacturing company.

Special Knowledge or Skills Required:

• Knowledge of validation principles across multiple disciplines, for example, equipment, computerized systems, cleaning, and process validation.
• Experience in the application of cGMPs.
• Experience with qualification of laboratory equipment and instruments.
• Experience with aseptic processing.
• Strong statistical analysis understanding and practical use of statistical software.
• Ability to communicate with respect to technical or project management issues, both verbally and in written form.
• Demonstrated leadership ability and experience working with high performance organizations and project teams.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Ability to work hours necessary to support production and/or product transfer activities.
• Ability to present to and interact with Senior Management.

Special Knowledge or Skills Preferred:

• 5+ years’ related experience within a pharmaceutical, biotech, or related industry with a preference toward direct Gene Therapy/Cell Therapy industry experience.
• Small company and/or start-up experience.
• Experience in interactions with domestic and international regulatory agencies.
• Experience presenting to inspection auditors a plus.

Reporting Outline:

• This position reports to the Senior Manager, Quality Engineering
• Travel on an infrequent basis is required (0 to 15%) to support job responsibilities and commitments.
• Physical demands include the ability to walk 1-3 miles, stand for 3-6 hours, and lift 10 – 40 lbs. during a workday, as required.

Apply

Job Title: IT Help Desk Associate

Reports to: Director of Information Technology

Role Description:

We are currently seeking an IT Help Desk Associate to join the Forge Biologics team. This is an exciting opportunity to join a high growth gene therapy manufacturing and therapeutics development company located in Columbus, Ohio. The IT Help Desk Associate provides technical end-user support to Forge employees, teams, and executives. This position is the initial point of contact for technical support requests received by phone, e-mail or other methods. This position is responsible for installing, diagnosing, repairing, maintaining, and upgrading hardware and other IT equipment to ensure optimal performance. The successful candidate must provide quality support to end users with high degree of customer satisfaction in a timely manner by taking ownership of requests, utilizing their technical knowledge, resulting in resolution, delegation, or coordination of efforts with IT management.

Responsibilities:

• Assist users regarding support questions
• Be able to resolve support calls in a proficient amount of time while demonstrating above average customer service skills
• Efficiently escalate issue's that require additional support
• Assist in implementations for new business as well as change requests through user training, unit testing, as well as process document creation
• Install and maintain PCs, Printers and other computer equipment and electronics • Software/System upgrades
• Perform any other job requirements as directed by the Manager

Requirements:

• Associates Degree or Equivalent Experience In IT Related Field
• Microsoft Office 365
• Microsoft Windows
• Apple Device/macOS Experience is preferred
• Good organizational and analytical skills
• Exhibits a high level of initiative and integrity
• Troubleshooting skills
• Basic understanding of network skills
• Willingness to work off hours if needed

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Job Title: Logistics Manager

Reports to: Director, Supply Chain & Facilities

Role Description:

We are currently seeking a Logistics Manager to join the Forge Biologics team. In this role, the Logistics Manager will directly contribute to the strategic, operational, and supply chain activities required to support our cGMP manufacturing programs and vision. This role will manage all cGMP assets and personnel in the supply chain operations department for both internal and external gene therapy programs.

This is an exciting opportunity to provide leadership and oversight of the required services and systems to make our organization successful. The candidate will lead a team of Supply Operations (Ops.) personnel to work with vendors, internal users, and external clients to support GMP and business operations. The candidate will serve to assure all groups are properly supported and integrated into new systems and communications to support future growth and the Forge strategic vision.

The Logistics Manager will have oversite of the receiving, storage, handling and shipping functions and will be responsible for coordination of these teams in synergy with all internal groups to assure schedule attainment for our internal and external clients. The Logistics Manager will play a crucial role in developing and maintaining these teams and will be the local subject matter expert for all regulatory inspections for all supply operations related activities. Additionally, the candidate will lead/participate in addressing specific Regulatory Agency responses.

This role will take part in coordinating and participating in construction efforts for continued growth of the facility as well as the continued support of the facility moving forward. The individual chosen for this position will work in close partnership with all branches of the Forge operations leadership team. The focus of this management role is to employ learned approaches to ensure Forge provides and maintains a state of the art AAV facility for pre-clinical, clinical, and commercial viral vector products, working in close partnership with internal and external experts to realize this goal.

To this end, the Logistics Manager will keep current on new technologies, and regulatory requirements that may have an impact on the company’s development, while ensuring adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Responsibilities:

• Provides strategic and operational management of the supply chain department responsible for material handling of items required for producing viral vector/gene therapy products.
• Accountable for ensuring adherence to strict regulatory requirements to ensure product quality.
• Works with all internal teams at Forge and across the operations team to ensure effective communication between all groups.
• Assists and coordinates review of all asset protocols, reports, records, and procedures to assure compliance and completeness.
• Participates in the hiring, training and leadership of the Supply Operations (Op) team.
• Manages and mentors staff to build a highly functional operations team that may be cross-trained in multiple areas, as needed.
• Works directly with Operations Leadership to assure process communications are occurring in a timely manner and budget and timelines are being adhered to.
• Supports business development activities including vendor and contractor selection as well as resource and response generation for bids and project budgeting.
• Develop the processes and systems that support GMP material handling activities including receiving, storing, labeling, testing, controlling and shipping pharmaceutical products or materials
• Support activities related to any cold chain preparation, shipping or packaging validation efforts Provides support and resources needed for the implementation and maintenance of warehouse safety and security programs and activities.
• Develops the materials space requirement plan, inventory plan and operational schedules for execution with our supply chain partners and in concert with the Demand Plan.
• Monitors inventory levels of products or materials in warehouse(s)
• Works with Finance on end of month inventory reconciliation
• Organizes material according to set standards regarding order, clarity, conciseness, style, and terminology
• Maintains records and files of work and revisions
• Manages the SMOG (Slow Moving/Obsolete Goods) program and coordinates disposition with Forge partners to maximize inventory valuation
• Manages Inventory Control Programs.
• Supports regulatory efforts and customer visits by acting as area SME (Subject Matter Expert) tour lead
• Verifies inventory computations by comparing them to physical counts of stock, and investigate discrepancies or adjust errors.
• Provides leadership, development opportunities and succession planning to all supply operations personnel

Requirements:

• Bachelor’s Degree or 10+ years supply chain/logistics experience
• Minimum of 5 years’ experience in biopharmaceutical manufacturing or regulated supply chain activities preferred
• Must be self-motivating, organized and proactive
• Strong technical aptitude including demonstrated experience in applying scientific reasoning to solve complex problems.
• Ability to work hours necessary to support production and/or product transfer activities
• Computers and Electronics - Knowledge of electronic equipment, and computer hardware and software, including supply chain and inventory applications.

Reporting Outline:

• This position reports to the Director of Supply Chain & Facilities
• Travel on an infrequent basis is required (<5%) to support job responsibilities and commitments.

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