Job Title: Senior Engineer II, Downstream Development, Viral Vector Product Development
Location: Cambridge, Massachusetts, United States
Job ID: R-224383
Date posted: 11/04/2025
About the Company:
AstraZeneca is a global biopharmaceutical company driven by the desire to make a real difference in patients’ lives. We focus on areas of high unmet medical need and harness the latest advancements in science and technology to deliver life-changing medicines.
Job Responsibilities:
Process Development and Optimization:
Lead bench-scale early and late-phase process development activities for Adeno-Associated Virus (AAV) purification processes (chromatography, filtration, UF/DF)
Design and execute experiments (OFAT and DoE-directed) to identify critical process parameters and recommend acceptable ranges for large-scale manufacturing
Enhance lab-based purification development strategies and implement next-generation tools to improve throughput and efficiency
Mentorship and Team Development:
Provide mentorship to junior lab members, improving team skills in experimental design and lab techniques
Serve as a purification Subject Matter Expert (SME) and contribute to knowledge expansion in the team
Scale-up and Tech Transfer:
Lead the scale-up and GLP manufacturing planning for processes up to 200L scale
Support tech-transfer activities, including providing on-site assistance (person-in-plant support) when necessary
Documentation and Regulatory Support:
Author development reports, tech-transfer documents, and other relevant process/regulatory documents for pipeline programs
Contribute to regulatory submissions (IND, IMPD, BLA) by drafting CMC sections
Innovation and Technology Evaluation:
Engage in platform development for the evaluation and implementation of novel technologies to enhance purification efficiency and product quality
Required Qualifications:
Education:
BS, MS, or PhD in Chemical Engineering, Biochemistry, or related discipline
Experience:
10+ years (BS), 8+ years (MS), or 2+ years (PhD) of relevant experience in the biotech industry
Extensive experience in biologics purification (Clarification, chromatography, UF/DF, NFF)
Proven expertise in high-throughput purification screening techniques and novel technology evaluation
Skills:
Experience with scale-up, tech-transfer, and implementation of purification processes at internal and external manufacturing sites
Proficiency in statistical analysis and design of experiments (DoE) using software such as JMP
Expertise in authoring technical documents (process development, tech transfer, batch records, IND supporting documents)
Preferred Qualifications:
Experience:
Experience in developing AAV-specific purification processes
Familiarity with molecular or physical biology analytical techniques (qPCR, ELISA, HPLC)
Other:
Strong team collaboration and leadership skills
Ability to recognize and address critical issues during the scale-up process
Ability to work in a controlled lab environment with biological, infectious, and hazardous materials
Compensation and Benefits:
Salary:
Base salary ranges from $110,000 to $166,000, depending on experience and location
Benefits:
Health benefits including medical, prescription drug, dental, and vision coverage
Paid vacation and holidays
Retirement plan (401(k)) and equity-based long-term incentives
Short-term incentive bonus opportunity
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