Senior Engineer II, Downstream Development, Viral Vector Product Development

About the position

Are you ready to make a significant impact in the field of viral vector process development? As a Senior Engineer II in Downstream Development, you will lead the design and execution of experiments to optimize Adeno-Associated Virus (AAV) manufacturing processes. You will act as a purification Subject Matter Expert (SME) and mentor junior colleagues, expanding team capabilities and generating critical experimental data. Your expertise will guide the development of robust and scalable manufacturing processes, and you will play a key role in drafting documentation, assisting in scale-up, tech transfer, and regulatory submissions.

Responsibilities

• Lead bench-scale early and late phase process development activities and optimization of AAV purification process steps (chromatography, filtration, UF/DF)
• Enhance the lab-based purification development strategy and implement next-generation tools to increase throughput and efficiency
• Design and execute OFAT and DoE-directed experiments to identify key and critical process parameters and recommend acceptable ranges for process scale-up large-scale manufacturing
• Participate on CMC program teams as a process development functional representative, providing updates and ensuring process development milestones are met
• Serve as SME for scale-up and GLP manufacturing planning and execution up to 200L scale
• Provide mentorship to junior lab members to improve team skills around experimental design and lab techniques
• Lead tech-transfer of manufacturing processes to external partners, providing person-in-plant (PIP) support when necessary
• Author development reports, tech transfer documents, and other relevant process/regulatory documents for pipeline programs and research collaborations
• Engage in platform development for the evaluation and implementation of novel technologies to improve purification efficiency and product quality

Requirements

• BS, MS, or PhD in Chemical Engineering, Biochemistry, or related discipline with 10+ years (BS), 8+ years (MS), or 2+ years (PhD) of relevant experience in the biotech industry
• Extensive experience developing biologics purification process steps (Clarification, chromatography, UF/DF, NFF)
• Experience developing high-throughput purification screening techniques and novel technology evaluation
• Experience managing scale-up, tech-transfer, and implementation of purification processes at internal and external manufacturing partners
• Expertise with statistical analysis and design of experiment (DOE)
• 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)
• Proficiency with statistical analysis and design of experiment (DOE) using software tools such as JMP
• Ability to work comfortably in a controlled lab environment with biological, infectious, and hazardous materials; lift/carry 15/30 pounds unassisted/assisted; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem-solving and non-linear thought; collaborate with others; maintain general availability during standard business hours

Nice-to-haves

• Experience developing AAV-specific purification processes
• Experience with participation in project teams and regulatory documentation
• Understanding of molecular or physical biology analytical techniques (qPCR, ELISA, HPLC) is a plus

Benefits

• 401(k) plan
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage