Senior Manager/Associate Director, GMP Manufacturing - Downstream

Company Overview:

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. Forge has a 200,000 ft2 facility in Columbus, Ohio, "The Hearth," to serve as their headquarters. The Hearth is the home of a custom-designed cGMP facility dedicated to AAV viral vector manufacturing and will host end-to-end manufacturing services to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing. By taking a patients-first approach, Forge aims to accelerate the timelines of these transformative medicines for those who need them the most.

Job Overview:

We are currently seeking a Senior Manager/Associate Director, GMP Manufacturing - Downstream to join the Forge Biologics team. This is an exciting opportunity to provide active leadership and execution of downstream activities according to Standard Operating Procedures and Master Production Records within Forge's state-of-the-art cleanroom facility, including units of operation for depth filtration, tangential flow filtration, chromatography and ultracentrifugation. The role will manage teams of technicians and Subject Matter Experts who implement and perform downstream processes, interacting with clients to complete projects for Drug Substance according to client specifications. 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 Senior Director of Downstream GMP Manufacturing and is responsible for leading a team in planning and managing for downstream activities, process optimization, and technology transfer to cGMP for virus (rAAV) vectors produced in mammalian and insect cells. Work activities will also include compiling data, drafting and reviewing documentation and preparing production report summaries, and presenting findings to internal and external parties with minimal supervision. It is expected that the ideal candidate will lead and participate as part of the GMP Manufacturing team while accomplishing the timely completion of assignments and reporting of unexpected issues.

Job Duties/Responsibilities:

• Lead downstream technologies related to gene therapy GMP manufacturing using systems in a cleanroom environment.
• Serve as the expert on the specific equipment associated with downstream activities, such as column packing/testing, TFF, and Affinity/Anion Exchange Chromatography.
• Complete documentation concurrently with completion of manufacturing processes.
• Support internal process transfer activities from Process Development to GMP
• Compile data with minimal oversight and author results for reports, and summaries
• Collaborate with Quality Systems, including QA and QC, to work toward efforts that satisfy GMP regulations and guidances.
• Support the performance of aseptic media simulations (APS)
• Lead responses and investigations for quality events, such as deviations and issue escalations.
• Train and mentor technicians and subject matter experts; perform periodic review of direct reports
• Additional responsibilities not listed may be assigned as needed by leadership

Requirements:

• BS with at least 8 years' experience, MS with at least 6 years' experience or Ph.D. with 4 or more years of experience; at least five years of industry experience
• Working knowledge of downstream activities, such as column packing/testing, TFF, and Affinity/Anion Exchange Chromatography
• Working knowledge of cGMP requirements and biological drug development
• Prior experience leading or mentoring a team of technicians/associates
• Excellent communication, technical, and organizational skills are required
• Critical thinking, troubleshooting, and attention to detail
• Strong leadership skills and ability to effectively manage a team of high performers
• Must be self-motivating, organized, and proactive.
• Strong technical aptitude including demonstrated experience in applying scientific reasoning to solve complex problems
• Ability to work the hours necessary to support production and/or product transfer activities