Manager, Quality Control (Analytical)

About Forge

Forge, a member of Ajinomoto Bio-Pharma Services, is a gene therapy development engine, focused on enabling access to life changing gene therapies and helping bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups. We bring expertise in gene therapy manufacturing and therapeutics development to the table, helping to champion teams that are navigating the long road from the lab bench to the bedside. Our goal is simple but vital to patients living with disease, and we take it seriously. With a patient-first approach, we are forging new models for working together to better accelerate these transformative medicines to reach those who need them the most.

Forge is based in Columbus, Ohio, in a 200,000 square foot facility known affectionately by team members as, the Hearth. The Hearth, is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services.

 

About The Role:

The Manager, Quality Control (Analytical) provides oversightof in-process and final product testing for AAV vectors, plasmids, and microbial and mammalian cell banks, while ensuring that activities occur in an efficient and cGMP compliant manner.  This position will serve as the subject matter expert (SME) for nucleic acid-based analytical testing within the QC team, with a primary focus on ddPCR and qPCR assays. This role will function as an SME for regulatory inspections, and will responsible for the supervision and management of direct reports within the QC Analytical team.  This role provides an opportunity to play a significant impact in the success of client gene therapy programs.

 

What You'll Do:

• Provide operational management of the Quality Control (QC) analytical team responsible for performing assays relevant to viral vector/gene therapy products, plasmids, and cell banks, including in-process testing, lot release testing, assay qualification, and validations.
• Function as the QC Analytical management team SME for nucleic-acid based analytical testing.
• Ensure adherence to strict regulatory requirements to ensure product quality.
• Collaborate with the Analytical Development (AD) and Manufacturing teams to ensure effective communication between all groups.
• Provide management for and ensure the effective transfer of analytical methods to Quality Control in a phase-appropriate fashion, to support pre-clinical, clinical, and commercial activities.
• Contribute to authoring, reviewing, and approving QC documentation: SOPs, protocols, analytical methods, stability protocols and reports, qualification protocols, sampling plans, and
• Ensure adherence to timelines in support of IND, BLA, and all relevant ex-US regulatory filings.
• Manage and mentor staff to build a highly functional QC team that may be cross-trained in analytical development assay areas, as needed.
• Provide support for Lab Investigations, Deviations, Change Controls, and CAPAs related to in process and final product testing.
• Manage tracking and trending of in process and final product testing data, including, but not limited to; leading/participating in out of specification (OOS)/out of trend (OOT) Laboratory Investigations.
• Ensure all laboratory records adhere to cGMP/GDP expectations.
• Support regulatory and client inspections, and internal audits .

 

What You'll Bring:

• Bachelor's, Master's, or PhD or in a relevant scientific field (e.g., biology, biochemistry, molecular biology)
• Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports.
• Experience with the analytical methods used for gene therapy in-process testing, release testing and characterization, with an emphasis on nucleic acid based assays (ddPCR, qPCR).
• SME for nucleic acid based assays (ddPCR, qPCR). Highly beneficial to have advanced knowledge of analytical testing quality control assays, including  ELISA, SDS-PAGE, Western blot, and HPLC, to assess the quality, potency, and safety of AAV vector products.
• Knowledge of cGMP requirements as they pertain to  Quality Control testing.
• Experience with electronic Quality Management Systems (eQMS), Laboratory Information Management Systems (LIMS), etc.
• Experience in support client or regulatory audits. High-level interactions with domestic and international Regulatory agencies is a plus.
• Knowledge of CMC analytical and regulatory requirements

 

Special Knowledge or Skills Preferred:

• Experience with the analytical methods used for gene therapy in-process testing, release testing and ch