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, 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. 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 guidelines.

In 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 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.

#AR&D

Required Skills:

Analytical Chemistry, Analytical Method Development, Analytical Testing, Bioanalytical Analysis, FDA Regulations, Good Manufacturing Practices (GMP), Liquid Chromatography (LC), Materials Testing, Pharmaceutical Industry, Pharmaceutical Sciences, Pre-Clinical Developments, Raw Materials, Regulatory Inspections, Release Testing, Stability Testing

Preferred Skills:

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The primary location for this posting is:

• USA - New Jersey - Rahway
• Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

• $156,900.00 - $247,000.00
• This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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 https://jobs.merck.com/us/en/compensation-and-benefits .

Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

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