Engineer III - Downstream, Viral Vector Product Development
Alexion Pharmaceuticals
- Lexington, MA
- Permanent
- Full-time
- Perform early and late phase process development and optimization of AAV purification process steps (chromatography, filtration, UF/DF)
- Lead the design and execution of 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
- Document experiments, compile analytical data, and summarize findings in lab notebook entries and reports to facilitate scale up and tech transfer activities.
- Coordinate with process analytics and method development team to align sample submission requests and process workflows
- Support 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
- Contribute to CMC program teams, providing updates and ensuring process development milestones and requirements are met
- BS or MS degree in Chemical Engineering, Biochemistry, or related discipline w/ 5+ years (BS) or 3+ years (MS) of relevant experience in the biotech industry
- Experience developing biologics purification process steps (Clarification, chromatography, UF/DF, NFF)
- Experience with statistical analysis and design of experiment (DOE) using software tools such as JMP
- Experience drafting process development reports, tech transfer documents, and other relevant process/regulatory documents
- 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.
- Experience developing AAV specific purification processes (Clarification, NFF, chromatography, UF/DF)
- Experience developing high-throughput purification screening techniques with liquid handlers or other tools
- Experience or understanding of molecular or physical biology analytical techniques (qPCR, ELISA, HPLC)