Senior Engineer - Downstream

Senior Engineer - Downstream, Viral Vector Product Development

This is what you will do:

The Senior Engineer Downstream contributes to the Viral Vector Process Development group through lab leadership around the design and execution of experiments to optimize AAV (Adeno-Associated Virus) manufacturing processes. The engineer will act as a purification SME as well as a mentor to junior colleagues to expand team capabilities and generate, interpret, and present experimental data to inform and recommend operating process operating conditions with the goal of developing robust and scalable manufacturing processes. They will additionally lead the drafting of documentation and provide expertise to assist in scale-up and tech transfer to clinical/commercial manufacturing facilities as well as submission of regulatory filings.

You will be responsible for:

• 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 high-throughput and other next generation tools to increase throughput and efficiency
• Work with downstream team members to design and execute OFAT and DoE-directed experiments to identify key and critical process parameters and to identify and recommend acceptable ranges for process scale-up large-scale manufacturing
• 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. At times provide person-in-plant (PIP) support to ensure successful operation
• 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
• Participate on 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), 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 with liquid handlers or other tools
• 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)
• Experience with statistical analysis and design of experiment (DOE) using software tools such as JMP
• The duties of this role are generally 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 purification processes
• Experience or understanding of molecular or physical biology analytical techniques (qPCR, ELISA, hPLC) is a plus

Date Posted

11-Sep-2024

Closing Date

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.