Senior Manager/Associate Director, GMP Manufacturing - Downstream

Job Title:  Senior Manager/Associate Director, GMP Manufacturing – Downstream

 

Role Description:

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 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.

 

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

 

Competencies Required:

• 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
• Ability to work collaboratively and across different functions in a fast-paced environment is required

 

Requirements:

• BS with at least 15 years’ experience, MS with at least 12 years’ experience or Ph.D. with 6 or more years of experience; at least five years of industry experience
• Experience in downstream technologies related to sterile filtration and sterile injectables.
• Working knowledge of downstream techniques and automated filling systems.
• Experience with filling of liquid biological products is required; experience with lyophilization is preferred.
• Working knowledge of cGMP requirements and biological drug development is required.
• 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
• Ability to work in loud noise environments and in Personal Protective Equipment (PPE) 

 

Reporting Outline:

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