Lead, GMP Manufacturing - Downstream

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  

We are currently seeking a Lead, GMP Manufacturing - Downstream to join the Forge Biologics team. This is an exciting opportunity to provide active leadership and execution of the Standard Operating Procedures and Master Production Records for downstream manufacturing processes within Forge’s state-of-the-art cleanroom facility. The role will manage a team of technicians at various levels who implement and perform downstream operations, interacting with clients to complete projects for viral vector purification methods 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.

What You’ll Do  

• Lead downstream operations for the purification of viral-based vectors related to gene therapy GMP in a cleanroom environment.
• Planning and managing for downstream activities, process optimization, and technology transfer to cGMP for viral vectors.
• Demonstrate proficiency on the specific equipment associated with downstream processes, such as column packing/testing, TFF, and Affinity/Anion Exchange Chromatography.
• Complete and review documentation concurrently with completion of manufacturing processes.
• Collaborate with MS&T to support internal process transfer activities from Process Development to GMP.
• Compile data with minimal oversight to author reports and analyze results for client facing summaries.
• Collaborate with Quality Systems, including QA and QC, to work toward efforts that satisfy GMP regulations and guidances.
• Train and mentor junior technicians; perform periodic review of direct reports.
• Reporting of unexpected issues by initiating deviations, participating in investigation, determining root cause and implementing CAPA.
• Work with Technical Writing team to draft, revise and review GMP documentation.

What You’ll Bring  

• Minimum of 4 years of relevant experience in downstream GMP manufacturing, with additional preference for relevant BS or MS degrees
• Demonstrated experience in downstream techniques, including column packing/testing, tangential flow filtration (TFF), and affinity/anion exchange chromatography
• Proficiency in purification processes, such as chromatography, filtration, and centrifugation, with a proven ability to operate and troubleshoot equipment in downstream GMP manufacturing environments
• Working knowledge of cGMP requirements and biological drug development
• 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)

 Preferred Skills   

• Working knowledge of aseptic techniques and automated systems
• Experience with gene therapy manufacturing and proficiency in using single-use technologies within a GMP downstream processing environment

Work Environment and Physical Demands  

This position works in both a laboratory environment and typic