Senior Scientist, Analytical Chemistry & Compliance
About The Position
The Analytical Commercialization Technology (ACT) department within Analytical Chemistry in Development and Supply (ACDS) is seeking an applicant for a Senior 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 Senior 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.
Requirements
- Bachelor’s degree in Chemistry or related discipline with at least five (5) years of required experience and skills [Master’s degree with at least three (3) years] in the pharmaceutical industry.
- Familiarity with regulatory compliance principles [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.
- 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.
Nice To Haves
- Experience authoring deviations and investigations.
- Experience leading cross-functional teams.
- Experience mentoring others.
- Experience implementing digital tools in the workplace.
Responsibilities
- 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
- Participating in or leading cross-functional compliance initiatives
Benefits
- medical
- dental
- vision healthcare
- other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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What This Job Offers
Job Type
Full-time
Career Level
Senior
