Scientist II, Process Development

Scientist II, Process Development - Upstream

Forge Biologics believes in turning bold ideas into life‑changing realities. Our mission is to enable access to life‑changing gene therapies and bring them from ideas into reality. We partner with scientists, physicians, biotech and pharma innovators, and patient communities—all united by one goal: improving lives. If you’re driven by purpose and excited to make a tangible impact, this is where your journey begins.

The Scientist II provides active leadership and execution of the laboratory experiments and protocols for upstream process development efforts. This individual will lead projects and complex experiments, train junior scientists, and actively contribute to the advancement of AAV manufacturing processes.

• Senior‑level technical contributor and subject matter expert for upstream systems and process strategy.
• Independently manage multiple projects or client programs simultaneously, maintaining a high degree of quality, scientific rigor, and compliance.
• Lead process development activities for early‑to‑late‑stage programs, including scale‑up, technology transfer, and validation support.
• Design and execute complex DoE studies, author technical reports, and contribute to regulatory documentation.
• Anticipate challenges in upstream scale‑up and proactively develop solutions to ensure technical success.
• Act as a key liaison between Process Development, Manufacturing, and Quality teams to align on strategy and ensure smooth GMP execution.
• Contribute scientific rationale for tech transfer packages and GMP documentation without owning official SOPs or batch records.
• Mentor junior scientists and associates through day‑to‑day technical guidance, fostering development in experimental design, documentation standards, and scientific reasoning.

• Bachelor’s Degree in Chemical Engineering, Bioengineering, Biology, or related discipline (or equivalent experience).
• Working knowledge of cell culture techniques utilizing mammalian cells.
• Proven ability to operate and troubleshoot bioreactors.
• Experience planning, conducting, and reviewing experimental data with minimal oversight.
• Experience training and development of other team members.
• Experience analyzing data sets and utilizing the corresponding data to influence decision making.
• Experience working with external collaborators (clients, external technology transfers, etc.).
• Project management experience.

• Master’s Degree or PhD in Chemical Engineering, Bioengineering, Biology, or related discipline (or equivalent experience).
• Experience working with viral vectors (AAV, Lentivirus, etc.).
• Experience in late‑stage process development, process characterization, risk assessments (e.g., FMEA).
• Hands‑on experience with Am ® 250 and other bench‑scale bioreactor systems.
• Hands‑on experience in design of experiments and with statistical software (e.g., JMP).

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.

This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment.

Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area.

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 discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics,…