Senior Leader, Small Molecule Analytical Chemistry

HireLifeScience

West Point (PA)

On-site

USD 173,000 - 273,000

Full time

3 days ago

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Job summary

HireLifeScience seeks a Principal Scientist to join the Analytical Commercialization Technology (ACT) group in Analytical Chemistry within Development and Supply (ACDS) at Rahway, NJ and West Point, PA sites.

You will lead a collaborative team applying analytical characterization technologies to drive late-stage small molecule drug product development and commercialization, with responsibility for method development, validation, and regulatory documentation.

Qualifications

PhD in Analytical Chemistry or related discipline with seven or more (7+) years of relevant small molecule pharmaceutical development experience; OR MS with ten or more (10+) years.
Strong background with UHPLC/HPLC, Dissolution, GC, UV, IR spectroscopy, and Karl Fischer titration.
Extensive experience with method development and validation.
Significant experience authoring CTD sections of regulatory submissions (IND, NDA, MAA, JNDA, etc.).

Responsibilities

Lead a team of scientists in analytical method development and validation, drug product testing, and analytical investigations in a cGMP environment.
Oversee drug product and manufacturing process characterization, stability studies, and specification development.
Support manufacturing process scale-up and validation.
Prepare CMC documents for global regulatory submissions and respond to regulatory questions.
Collaborate with cross-functional teams including regulatory, research and manufacturing.