Senior Scientist, Injectable Drug Product Development

Alexion

New Haven (CT)

On-site

USD 150,000 - 210,000

Full time

3 days ago

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Job summary

Alexion seeks a Senior Scientist to lead drug product development for parenteral biologics, guiding DS/DP processes from scale-up through commercial validation. You will manage cross-functional teams, design development studies, and drive technology transfer across sites.

Strong expertise in protein biochemistry and biopharmaceutical assays is essential. The role involves collaboration with Analytical Development, Quality, CMC, and Regulatory Affairs, with on-site laboratory work and rigorous

Qualifications

PhD with a minimum of 2+ years' relevant research experience or MS with 11+ years, BS with 12+ years is acceptable.
Hands-on experience in biotherapeutics drug product development and related manufacturing unit operations.
Knowledge of cGMP and Quality expectations; experience with electronic QA systems is a plus.

Responsibilities

Lead drug product development teams with multiple cross-functional stakeholders.
Design and execute development studies for internal and contract manufacturing sites.
Coordinate technology transfer activities and ensure timely completion of studies and reports.
Analyze data and author technical reports for regulatory filings or internal documentation.
Stay current with literature on drug product manufacturing and regulatory expectations.
Prepare presentations for internal and external stakeholders and lead meetings.