Scientist II, Upstream Process Development

Scientist II, Upstream Process Development

Lexington, MA

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.

Direct the development and establishment of processes in Process Development. This individual is accountable for developing a scalable platform for viral vector production processes that minimizes the risk during Process Development to GMP scale‑up. The individual will provide technical expertise and leadership in science & technology and requires close collaboration with internal stakeholders.

• Design and execute upstream process development activities and identify opportunities to improve process yield, product safety, and product quality.
• Write and review experimental protocols, batch production records, experimental reports.
• Analyze, review, and communicate data to senior management and team members.
• Be accountable for supporting the establishment of upstream gene therapy drug substance development platform from small scale through intermediate scale (50 L) for adeno‑associated virus, lentiviral and retroviral vector processes.
• Train and mentor research associates.
• Maintain open communication via one‑on‑one and team meetings.
• Stay current with relevant technologies and need to be adept at identifying new approaches.
• Responsible for the process transfer activities from/to clients and to in‑house manufacturing team(s), such as creation of bill of materials and sampling plan, generation of process description documents, technology transfer reports; provide process training to MSAT and manufacturing teams and assist with process troubleshooting and deviations during GMP production.
• Maintain external technical relationships and collaborate with equipment and material suppliers.
• Serve as process SME for client‑facing and internal programs.
• Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the assigned functional area.

• Adaptability required as work schedule may change based on business needs.
• Criminal background check required.
• Other duties as assigned.

• BS or MS in biochemistry, chemical engineering, molecular biology, or related field.
• 4–8+ years of relevant industry experience.
• Experience with cell culture technologies, molecular biology, upstream processing, and aseptic processing.
• Pharmaceutical industry experience in technical support of cGMP manufacturing and/or process development, including experience with Contract Development and Manufacturing Organizations.
• Solid foundation in the fundamentals of biochemical engineering, virology and cell biology.
• Entrepreneurial experience dealing with customers in product development.

• Working knowledge of upstream process (cell culture, aseptic technique, bioreactor operations). Hands‑on experience with complex biologics e.g. gene therapy, transient transfection, baculovirus infection.
• Process design and bioreactor scale‑up, cGMP manufacturing.
• Ability to interface successfully with multi‑disciplined teams.
• Extremely detail‑oriented with strong technical skills and mechanically inclined.

• Work in a BSL‑2 environment with PPE/aseptic gowning.
• Work around large machinery and typical utilities in pharmaceutical facilities.
• Occasionally exposed to moving mechanical parts, high places, toxic or caustic chemicals, hazardous waste, and risk of electrical shock.
• Occasionally exposed to extremely loud noise levels.
• Spend time on the floor during activity execution (maintenance, construction, commissioning and qualification).

The annual salary range for this position is $100,000‑$120,000.

• Paid vacation days, amount based on tenure.
• 401(k) plan with company matching up to 6% of salary, vesting immediately.
• Choice of several healthcare plans.
• FSA and HSA programs.
• Employer‑paid basic term life/personal accident insurance.
• Voluntary disability, universal life/personal accident insurance.

Genezen is an Equal Opportunity Employer. Genezen participates in EVerify. Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.