Forge Biologics - Columbus, OH
posted 3 days ago
About the position
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.
Responsibilities
- Lead and oversee complex experiments for AAV upstream process development, utilizing single-use bioreactors and advanced techniques.
- Provide technical expertise in bioreactor operation, cell culture, and transfection, acting as the Subject Matter Expert (SME).
- Drive process optimization initiatives to enhance AAV yields, quality, and scalability, contributing to project leadership.
- Conduct independent research and lead projects, compiling and contributing experimental data for publications or reports.
- Independently present results and prepare publications or reports, demonstrating strong communication skills.
- Manage and mentor junior team members, reviewing experimental data and providing guidance and direction.
- Perform individual performance reviews, providing coaching/feedback to ensure employee development.
- Generate protocols/templates that can be utilized by junior team members.
- Develop and revise standard operating procedures (SOPs) and batch records to ensure process consistency.
- Contribute to the development and implementation of innovative process development strategies.
- Oversee day-to-day laboratory activities, including equipment maintenance, supplies management, and cleanliness.
- Support internal process transfer activities from Process Development to GMP.
- Demonstrate a breadth of scientific expertise (knowledge and technique) in laboratory functions that are pertinent to company goals.
- Collaborate cross-functionally with research and manufacturing teams to ensure seamless technology transfer and process implementation.
- Develop and execute process validation strategies and support regulatory filings.
- Stay current with advancements in AAV production technologies, gene therapy field, and regulatory requirements, and apply this knowledge to continuously improve processes and support business growth.
Requirements
- Bachelor's Degree in Chemical Engineering, Biomedical Engineering, Biology, or related discipline (or equivalent experience).
- Working knowledge of cell culture techniques utilizing mammalian, insect, or microbial cells.
- Technical expertise in upstream process development and scale up principles.
- Proven ability to operate and troubleshoot bioreactors.
- Experience planning, conducting and reviewing experimental data with minimal oversight.
- Experience analyzing data sets and utilizing the corresponding data to influence decision making.
- Prior experience working with internal/external stakeholders and presenting data to drive decisions.
- Experience directly managing junior team members.
Nice-to-haves
- Master's Degree or PhD in Chemical Engineering, Biomedical Engineering, Biology, or related discipline (or equivalent experience).
- Experience working with viral vectors (AAV, Lentivirus, etc.).
Benefits
- Health, Dental, and Vision insurance that starts on your first day at Forge, with 90% of premiums covered for team members as well as dependents
- Flexible PTO (plus 14 paid company holidays)
- Annual bonus for all full-time employees
- 401(K) company match
- Fully-stocked kitchen with free food/drinks
- 12 weeks of paid parental leave - additional discount programs include childcare support & dependent care
- Employee Assistance Program
- Wellness benefits (financial planning services, mental health counseling, employer paid disability)
- Professional & Personal development resources - LinkedIn Learning, a dedicate training staff in-house, mentoring opportunities & access to leadership development coaches
