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Director of Analytical Development

Apex Systems
Watertown, MA Full Time
POSTED ON 1/17/2025
AVAILABLE BEFORE 4/7/2025

Job# : 2055233

Job Description :

Director, Analytical Development 2055233

Location :  Cambridge, MA (Onsite)

Science :  Small Molecule Therapeutics

Job 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 CDMO’s 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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