Engineer II, Upstream Viral Vector Product Development

This is what you will do:

The Engineer II in the Upstream Process Development team will play a key role in the development of adeno-associated virus (AAV) production processes for gene therapy applications. This position involves working collaboratively with a multidisciplinary team to design, optimize, scale up, and tech transfer upstream processes involved in the production of viral vectors.

You will be responsible for:

• Support Upstream Development including the design and execution of laboratory experiments to develop and optimize upstream processes for AAV production, including cell culture, transfection, production, and harvest/lysis.

• Troubleshoot process-related challenges and implement corrective actions to optimize production yields and maintain product quality.

• Perform routine Upstream laboratory tasks such as shake flask and bioreactor sampling and cell maintenance.

• Manage and maintain lab equipment and supplies, ensuring a safe and efficient work environment. This includes regular lab cleaning, equipment maintenance, and supply procurement. 

• Analyze and interpret experimental data, utilizing statistical tools to drive scientific decision-making and process improvements.

• Collaborate with cross-functional teams including Downstream, Process Analytics, and Research. 

• Support the transfer of upstream processes to cGMP manufacturing.

• Document experiments and results clearly and accurately in production files and electronic laboratory notebooks; Summarize and present results to the broader team.

• Support the drafting of process development reports, process descriptions, and tech transfer documents.

You will need to have:

• BS or MS degree in Biomedical Engineering, Chemical Engineering, Biotechnology, or a related field

• Minimum of 2+ years of relevant experience in the biotech industry

• Hands-on experience with mammalian cell culture and aseptic technique

• High level of proficiency in MS Office software

• The duties of this role are generally conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

• Experience with bioreactor set up and operation.

• Experience with AAV or other viral vectorsand transient transfection

• Experience with statistical analysis and design of experiment (DOE)