Director of Analytical Development

Company: Apex Systems
Location: Cambridge
Posted on: January 21, 2025

Job Description:

Director, Analytical Development 2055233Location: Cambridge, MA (Onsite)Science: Small Molecule TherapeuticsJob Overview: In this role, you will lead Analytical Development for projects in clinical stage combining your expertise in small-molecule therapeutics and CMC activities to advance our clients' pipeline of clinical assets.Primary Job Responsibilities:

Develop analytical controls and stability studies for drug substances and products.
Collaborate on impurity controls and in-process test methods.
Validate critical analytical methodologies for different development stages.
Manage external analytical development testing labs and CDMOs to ensure project timelines are kept on track.Primary Job Requirements:
PhD with 10+ years in small molecule analytical development.
Deep expertise in test method development and cGMP stability studies.
Experienced in regulatory filings and managing external labs.
Strong problem-solving and leadership skills.
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Keywords: Apex Systems, Newton , Director of Analytical Development, Executive , Cambridge, Massachusetts

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