Senior Scientist, Analytical Chemistry & Compliance

Senior Scientist

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.

Minimum

Education 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.

Required

Experience and Skills:

• 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.

Preferred

Experience and Skills:

• Experience authoring deviations and investigations.
• Experience leading cross-functional teams.
• Experience mentoring others.
• Experience implementing digital tools in the workplace.

Required Skills:

Analytical Chemistry, Analytical Method Development, cGMP Regulations, Chemical Synthesis, Chromatography, Deviations, Flow Cytometry, Good Manufacturing Practices (GMP), Karl Fischer Titrations, Mass Spectrometry Based Proteomics, Mentorship, Pharmaceutical Development, Proper Documentation, Regulatory Compliance, Small Molecules, Spectroscopy

Preferred

Skills:

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The salary range for this role is

$ - $

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at

You can apply for this role through  (or via the Workday Jobs Hub if you are a current employee). The Final date to receive applications for this position is…