Senior Director, Quality Control

Job Title: Senior Director, Quality Control

Reports to: Vice President, Quality Management

Role Description:

We are currently seeking a Senior Director of Quality Control to join the Forge Biologics team.  The Senior 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 Senior Director manages the assets and personnel in the QC department and the QC activities for both internal and external gene therapy programs.

The Senior Director of QC will need to be successful 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 Senior Director of QC will have oversight of the Analytical teams at Forge, which include scientists, analysts, and technicians.  These teams serve a wide array of internal and external customers and require close coordination with Quality and Regulatory groups as well.  Additionally, the Senior Director will set-up, maintain, and trend these systems.  The Senior Director also serves as backup for oversight of Micro, Physical Monitoring, and Environmental Monitoring teams at Forge.

Responsibilities:

• 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.
• Responsible for stability testing and Drug Substance (DS)/Drug Product (DP) release and for all analytical activities.
• 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.
• Remains 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.
• Accountable for ensuring adherence to strict regulatory requirements to ensure product quality.
• 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 Leadership and Senior Management 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 GMP requirements from design through procurement, installation and operational readiness, and associated required documentation.
• Coordinate and participate in construction efforts for the phased build out of the facility, as well as the continued support of the facility moving forward.
• Support business development activities including vendor and contractor selection, as well as resource and response generation for bids and project budgeting.

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.
• 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 and biopharmaceuticals.
• Functional knowledge of mammalian cell culture.
• Prior experience with commercial release testing within CROs/CMOs/CDMOs.
• Demonstrated experience in departmental budgeting, CAPEX procurement, IQ/OQ, safety, and status reporting to Leadership and Senior Management.
• 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 Leadership and Senior Management.
• Minimum of 6+ years’ experience in leadership/management/supervision with a preference toward direct Gene Therapy/Cell Therapy industry experience.
• Experience in high-level interactions with domestic and international Regulatory agencies preferred.
• In our commitment to safety of our employees and customers a COVID vaccination is required.