Lead GMP Manufacturing - Drug Product/Fill Finish

1w1 week ago

Forge Biologics

Columbus, US · Full-time · $120,000 – $160,000

About this role

Forge Biologics is a hybrid gene therapy contract manufacturing and therapeutics development company. Forge’s mission is to enable access to life changing gene therapies and help bring them from idea into reality. The 200,000 ft2 facility in Columbus, Ohio, “The Hearth,” hosts a custom-designed cGMP facility for viral vector manufacturing.

The Lead GMP Manufacturing - Drug Product/Fill Finish provides active leadership and execution of Standard Operating Procedures and Master Production Records for manual, semi-automated, and fully automated Fill/Finish activities in a state-of-the-art cleanroom. The role leads a team of technicians and collaborates with Subject Matter Experts to prepare and perform fill/finish processes. Interact with clients to complete Drug Product Fill Approval according to specifications and expectations.

Drive continuous improvements in fill/finish technologies related to gene therapy GMP manufacturing. Maintain aseptic techniques throughout set up, filling, stoppering, and capping to ensure integral vial sealing. Manage communications with Downstream team for gating Titers and Retentate volumes in preparation of sterile filtration dilution schemes.

Oversee material requests, inventory control, and equipment compliance through PM, calibrations, and certifications. Collaborate with Quality Systems, QA, and QC to satisfy GMP regulations. Develop and mentor technicians while leading biannual aseptic media simulations.

Requirements

BS with at least 4 years’ experience, MS with at least 6 years’ experience or Ph.D. with 2 or more years of experience; experience may be substituted if candidate does not have higher level education
Skilled in technical problem-solving and laboratory techniques to support growth in the Gene Therapy sector
Experience leading fill/finish processes in GMP cleanroom environments
Knowledge of aseptic techniques and vial sealing in drug product manufacturing
Familiarity with cGMP AAV manufacturing and technology transfer
Proficiency in Good Documentation Practices for MPR and production reports
Ability to collaborate with QA, QC, and cross-functional teams on GMP compliance

Responsibilities

Lead fill/finish technologies related to gene therapy GMP manufacturing using manual, semi-automated and fully automated filling systems in a cleanroom environment
Plan and manage fill/finish activities, process optimization, and technology transfer to cGMP AAV manufacturing
Maintain aseptic techniques throughout fill/finish processing activities: set up, filling, stoppering, and capping ensuring integral vial sealing
Drive clean room preparedness through 5S design that promotes white glove excellence
Maintain ongoing communications with Downstream team to follow gating Titers and Retentate volumes for sterile filtration dilution scheme
Manage material requests, material transfers and inventory control per client production run
Maintain equipment compliance: PM, calibrations, and certifications through proactive communications with metrology and engineering
Lead preparedness, processing and review of biannual aseptic media simulations (APS)