Associate Principal Scientist, Analytical Characterization and Compliance

Job Description

The Analytical Commercialization Technology (ACT) department within Analytical Chemistry in Development and Supply (ACDS) is seeking an applicant for an Associate Principal Scientist position available at the West Point, PA site in the small molecule drug product Preliminary Stability Study testing laboratory.  The successful candidate will utilize analytical characterization technologies and compliance principles to drive method robustness and high-quality stability data in support of late-stage pharmaceutical drug product development and commercialization.  The Associate Principal Scientist responsibilities include, but are not limited to, stability sample analysis, leading analytical investigations in a cGMP environment, implementing new technology or continuous improvement measures for optimized laboratory operations, involvement in quality audits, and participating in or leading cross-functional compliance initiatives.  The successful candidate must have a proactive mindset and be able to collaborate in a dynamic, integrated, and multidisciplinary environment.

Minimum Education Requirement and Experience: 

Bachelor’s degree in chemistry or related discipline with eight (8) years of required experience and skills (Master’s degree with six (6) years, PhD with three (3) years) in the pharmaceutical industry.

Required Experience and Skills:

• Strong knowledge of regulatory compliance principals [Good Manufacturing Practices (GMPs), Good Documentation Practices (GDPs)] and quality assurance practices related to analytical testing of pharmaceutical products.
• Strong background and hands-on experience with common analytical characterization techniques such as UPLC/HPLC, dissolution, and/or Karl Fischer titration.
• Demonstrated leadership skills and problem-solving abilities with experience leading cross-functional teams or business initiatives.
• Excellent verbal and written communication skills.
• Ability to work in a team environment with cross-functional interactions.
• Effective organizational skills and ability to manage competing priorities.

Preferred Experience and Skills:

• People management or supervision experience.
• Experience implementing digital tools in the workplace.

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