Associate Director, GMP Manufacturing - Downstream

About Forge

Our mission at Forge Biologics, is to enable access to life changing gene therapies and help 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 Team

The GMP Manufacturing department is responsible for the manufacturing of AAV Gene Therapy products in accordance with the highest standards of Good Manufacturing Practices (GMPs). This department ensures that the products produced are of the highest quality and meet all applicable regulatory requirements. This team works together to ensure the production of safe and effective Gene Therapy products.

About The Role

The Associate Director, GMP Manufacturing – Downstream will 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.

What You’ll Do

• 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.

What You’ll Bring

• Bachelor’s Degree (B.A. or B.S.) in Biology, Biochemistry, Biomedical Engineering, or related life science field (or equivalent work experience)
• Proven track record of leading downstream manufacturing functions.
• Prior experience managing and leading technicians/associates.
• 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.
• Strong leadership skills and ability to effectively manage a team of high performers.
• 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.

Preferred Skills

• Advanced Degree in Biology, Biochemistry, Biomedical Engineering, or related life science field
• Experience in the purification of Viral Vectors such as AAV, Lentivirus, etc.

 

COVID Safety

In our commitment to the safety of our employees and customers, a COVID vaccination is required.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned.

Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits disc