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Alexion Pharmaceuticals, Inc. · 2 days ago
Scientist I, Upstream Process Development
New Haven, CT
Full-time
Onsite
Senior Level
8+ years exp
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Responsibilities
Develop and optimize robust and scalable drug substance manufacturing processes (upstream and downstream) for GMP manufacturing of biologics for clinical and commercial supply
Lead process scale-up evaluation and support process tech transfer to clinical and commercial manufacturing sites including C(D)MO
Lead external projects to evaluate and implement new platform or technology to improve the efficiency for current workflow
Lead small-scale model qualification and process characterization studies
Author internal technical protocols and reports which may have a strong interface with other technical functions, regulatory, and compliance
Serve as a subject matter expert for cell line/upstream/downstream processes across Alexion internal and external manufacturing network for clinical and commercial processes
Perform evaluation and due diligence for in-licensing, out-sourcing, or collaboration opportunities
Author and review regulatory submissions such as IND/BLA and response to questions from health authority
Develop and manage a group of associate scientists through direct supervision or as a matrix leader to support professional development. Lead functional/cross-functional project team
Qualification
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Required
A PhD in Biology/Chemistry/Chemical Engineering/Biological Sciences or related fields, MS with at least 8 years of experience, or BS with at least 10 years of experience in biotechnology/pharmaceutical industry
Technical knowledge of cell line, upstream, or downstream process development for biologics
Scientific principles and concepts in the field of process development
Technical proficiency, scientific creativity, learning agility, and ability to collaborate with others
The ability to troubleshoot small and large scale equipment used in upstream/purification processes in area of expertise, and to offer solutions is expected
Strong ability lead cross functional teams
Preferred
Working knowledge of regulatory guidelines related to cell line, upstream, or downstream development and process characterization including viral clearance and process validation
Experience in microbial strain engineering and fermentation process development, medium and feed development, aseptic techniques and bioreactor operation
Experience using AKTA systems and unicorn software for purification development
Knowledge and use of statistical analysis, multivariate data analysis and DOE
Experience in writing and reviewing process-related documents
Experience in manufacturing and regulatory support
Strong verbal and written communication and interpersonal skills
Strong ability for people management
Benefits
Health Insurance
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
Company data provided by crunchbase
