Principal Scientist, Raw Materials Center of Excellence Strategy Lead, Pharmaceutical Analysis and Digital Technologies

Job Description The Pharmaceutical Analysis and Digital Technologies (PADT) team has an opening for a Principal Scientist based in Rahway,  this role, the Principal Scientist will define and lead the strategy for the Raw Materials Center of Excellence (CoE), establishing harmonized, science- and risk-based approaches to raw material, excipient, and package component control and release testing across the entirety of our clinical portfolio including small molecule, biologics, and vaccines.

The Principal Scientist will serve as the technical authority for raw materials, ensuring that CoE standards, processes, and testing strategies support cGMP compliance, operational excellence, and a constant state of inspection readiness. The Principal Scientist should be engaged in regulatory, compendial, and industry trends and have thorough working knowledge of GMPs, ICH, USP/NF, and relevant FDA  addition, the Principal Scientist will partner with Analytical leadership across all modalities and cross-functional stakeholders in Quality, Procurement, Materials Management, and Pharmaceutical Sciences to translate portfolio and supply needs into a multi-year CoE roadmap.

The role will influence without direct authority, mentor scientists to build technical capability, and drive risk assessment, resource and capacity planning, and continuous improvement initiatives for the CoE.

Primary Responsibilities:

Define and drive the strategy, governance, and multi-year roadmap for the Raw Materials Center of Excellence Establish science- and risk-based raw material control strategies, including specification setting, supplier qualification input, and reduced testing programs, to enable on-time, right-first-time clinical manufacture

Provide technical oversight of contract laboratories and lead scientific support for raw material investigations, deviations, and CAPAsReview and approve GMP data, release specifications, analytical reports, Certificates of Analysis, and SOPs; author and own CoE standards and governance documents

Serve as the raw material SME during internal and external compliance audits and regulatory inspections

Monitor regulatory, compendial (USP/NF, Ph. Eur., JP), and industry trends; lead gap assessments and implementation plans

Champion operational excellence and efficiency in raw material testing through use of digital tools and innovative technologies while ensuring data integrity and right-first-time execution

Partner cross-functionally with Analytical Leadership, Quality, Procurement, Materials Management, and Pharmaceutical Sciences to align an integrated raw material strategy to meet the clinical portfolio and supply needs across all modalities

Mentor and develop scientists, building technical depth and raw materials expertise across the CoE Education

Minimum Requirements:

PhD Degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related fields with at least 7 years of pharmaceutical industry experience​.Master’s Degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related fields with at least 10 years of pharmaceutical industry experience. Bachelor’s Degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related fields with at least 12 years of pharmaceutical industry experience.
Required

Experience and Skills:

Extensive expertise in the analytical testing of raw materials, excipients, and/or package components, preferably within a cGMP environment, with comprehensive knowledge of GMPs, ICH guidelines, compendial requirements, and applicable FDA guidance

Demonstrated ability to develop and execute technical strategy and to exercise influence without direct authority within a matrixed organization

Excellent scientific communication,…