Associate Principal Scientist, Chemistry Full-time

Associate Principal Scientist

We are currently seeking an exceptional individual for an Associate Principal Scientist position within the Supply Analytical Sciences (SAS) – Analytical Chemistry in Development and Supply (ACDS) organization located in West Point, PA or Rahway, NJ. This position is a scientific role in a fast-paced, multidisciplinary team environment. The successful candidate will be joining a group of innovative analytical scientists with broad deliverables to support commercial pharmaceutical products ensuring undisrupted supply of our Company products to patients globally.

The incumbent is expected to interact closely with internal sites and external partners in our Company network in identifying issues/gaps and implementing solutions, providing strong analytical support such as troubleshooting laboratory test methods and workflows as well as material for ensuring compliant, robust, and responsive supply. The individual will have a deep understanding of the global regulatory and business environment and the needs related to pharmaceutical drug substance and drug product development, GMP compliance in commercial manufacturing and data integrity.

Responsibilities include:

• Lead and/or execute analytical method development, improvement, validation and/or transfer activities
• Author analytical procedures and/or methods development and validation protocols, technical reports, experimental designs, regulatory submission documents, etc.
• Lead and/or perform investigations with strong technical troubleshooting skills and assist in developing/implementing CAPAs.
• Provide documentation/technical input during inspections and audits (Regulatory and Internal).

Core competencies required for this role:

• Strong analytical chemistry knowledge and extensive experience in analytical development
• Demonstrated problem solving ability including the ability to perform investigations with strong technical troubleshooting skills
• Experience with common analytical techniques such as chromatography, spectroscopy, dissolution and Karl Fischer
• Strong communication (verbal and written) and interpersonal skills, demonstrated ability to work in an interdisciplinary team environment. Able to influence team direction for complex situations and navigate ambiguity
• Ability to quickly adapt to changes and develop appropriate plans for managing risks
• Strategic thinking and ability to articulate the “big” picture along with demonstrated ability in asking the right questions to drive critical conversations

Preferred experience and skills:

• Working knowledge of pharmaceutical drug substance and/or drug product development and commercialization
• Working knowledge of CMC filing requirements and regulatory guidances (e.g., ICH) for drug substance and/or drug product
• Working knowledge of GMP and data integrity and recent industry trends in commercial production space

Education minimum requirement:

• Bachelor's Degree in Chemistry or related discipline with at least ten (10) years of relevant pharmaceutical development experience, OR
• Master's Degree in Chemistry or related discipline with at least eight (8) years of relevant experience, OR
• PhD in Analytical Chemistry or related discipline with at least four (4) years of relevant experience