40 applicants
Alexion Pharmaceuticals, Inc. · 4 days ago
Senior Engineer - Downstream, Viral Vector Product Development
Lexington, MA
Full-time
Onsite
Senior Level
8+ years exp
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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 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
Qualification
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Required
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
Preferred
Experience developing AAV specific purification processes
Experience or understanding of molecular or physical biology analytical techniques (qPCR, ELISA, hPLC) is a plus
Company
Alexion Pharmaceuticals, Inc.
Alexion, AstraZeneca Rare Disease was created following the 2021 acquisition of Alexion Pharmaceuticals, Inc. by AstraZeneca.
1,001-5,000 employees
H1B Sponsorship
Alexion Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (34)
2022 (30)
2021 (26)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$5.8M2020-12-12Acquired· by AstraZeneca ($39B)
1999-02-12Post Ipo Equity· $5.8M
1996-03-08IPO· nasdaq:ALXN
Leadership Team
Ludwig N. Hantson
Chief Executive Officer
Frederic Chereau
SVP, Strategy and Business Development
Recent News
Yahoo Finance Canada
2024-04-29
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