Principal Scientist, Raw Materials Center of Excellence Strategy Lead, Pharmaceutical Analysis and Digital Technologies
Merck
Summary
The Pharmaceutical Analysis and Digital Technologies (PADT) team has an opening for a Principal Scientist based in Rahway, NJ. In 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.
Job description
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 CAPAs
- Review 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, creativity, and interpersonal skills
- Proven experience mentoring scientists and collaborating cross-functionally to deliver high-quality results within established timelines
- Strong coaching and collaboration skills, with the ability to work effectively in a team-based, cross-functional environment
Preferred Experience and Skills
Though not required, the ideal applicant would have experience establishing or leading a center of excellence or global harmonization initiative, risk-based raw material control strategies (e.g., reduced testing or supplier qualification programs), and contract laboratory oversight. Familiarity with compendial monograph changes, data/digital solutions for lab operations, and package or medical device components is a plus.
Requirements
- PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field with at least 7 years of pharmaceutical industry experience, OR Master's degree with at least 10 years, OR Bachelor's degree with at least 12 years
- Extensive expertise in analytical testing of raw materials, excipients, and/or package components
- Comprehensive knowledge of GMPs, ICH guidelines, compendial requirements, and applicable FDA guidance
- Demonstrated ability to develop and execute technical strategy and exercise influence without direct authority within a matrixed organization
- Excellent scientific communication, creativity, and interpersonal skills
- Proven experience mentoring scientists and collaborating cross-functionally
- Strong coaching and collaboration skills
Benefits
- Medical, Dental & Vision
- Retirement Benefits
- 401(k)
- Paid Holidays
- Vacation
- Compassionate & Sick Days
- Annual Bonus
- Long-Term Incentive
Company overview
Merck & Co., Inc., known as Merck in the United States and Canada and MSD (Merck Sharp & Dohme) internationally, is a premier American multinational pharmaceutical company headquartered in Rahway, New Jersey. Founded in 1891 as the U.S. subsidiary of the German Merck Group, the company became independent following World War I and has since grown into one of the world's largest biomedical companies, ranking fourth globally by revenue. Merck operates across three core business segments: pharmaceuticals, vaccines, and animal health products. The company is renowned for its groundbreaking research and development, having brought numerous life-saving medicines to market including Keytruda (pembrolizumab), a leading immunotherapy for cancer treatment that generated $29.5 billion in 2024 revenue, and Gardasil, a revolutionary HPV vaccine. With approximately 75,000 employees worldwide, Merck maintains a robust pipeline of innovative therapies focused on oncology, vaccines, hospital acute care, cardiology, neuroscience, virology, immunology, and diabetes. The company invests heavily in R&D, spending $17.9 billion in 2024 alone, demonstrating its commitment to advancing scientific discovery. Merck's legacy spans over 130 years of bringing hope to humanity through important medicines and vaccines, operating with a purpose to use leading-edge science to save and improve lives globally while fostering an inclusive workforce and responsible business practices.