Senior Engineer – Cell Line Development

The Senior Engineer Cell Line Development (CLD) contributes to the Viral Vector Process Development group through lab leadership around the design and production of novel viral vector plasmids and high-producing, high quality packaging and/or producer cell lines for AAV.

The engineer will function as a CLD subject matter expert and generate, interpret, and present experimental data from all aspects of cell line and plasmid generation to inform and recommend changes to the CLD platform. They will additionally lead the drafting of documentation and provide expertise to assist tech transfer to clinical/commercial manufacturing facilities as well as submission of regulatory filings.

You will be responsible for:

• Leading in the development and characterization of bench-scale plasmid engineering, transfection, transduction, and cell line construction for the generation of GMP-friendly cell lines
• Participating in the evaluation of novel technologies in vector construction (including promotor and other key elements) and producer/packaging cell line generation
• Implementing high-throughput and other next generation development and analytical tools to increase throughput and efficiency
• Working with upstream and Research team members to design and execute OFAT and DoE-directed experiments to identify key and critical process parameters
• Providing mentorship to junior lab members to improve team skills around experimental design and lab techniques.
• Leading tech-transfer of manufacturing processes to external partners. At times provide person-in-plant (PIP) support to ensure successful operation
• Authoring development reports, protocols, tech transfer documents, and other relevant process/regulatory documents for pipeline programs and research collaborations
• Participating in CMC program teams as a process development functional representative, providing updates and ensuring process development milestones and requirements are met
  
  
  

You will need to have:

• BS, MS, or PhD in Chemical Engineering, Biochemistry, or related discipline w/ 10+ years (BS), 8+ years (MS), 0-2+ years (PHD) of relevant experience in the biotech industry
• Experience in general and advanced lab techniques such as plasmid design and construction, molecular cloning, protein expression, and cell culture production processes
• Experience with statistical analysis and design of experiment (DOE) using software tools such as JMP
  
  
  

The duties of this role are conducted in an 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 developing AAV-specific transient transfection-based plasmids and cell lines
• Experience authoring technical documents (process development, tech transfer, batch records, IND supporting documents) and supporting drafting of CMC sections of regulatory submissions (IND, IMPD, BLA)
• Experience or understanding of molecular or physical biology analytical techniques (qPCR, ELISA, HPLC, etc.)