The posting
Job Description
Principal Scientist, Cleaning Verification Center of Excellence Strategy Lead, Pharmaceutical Analysis and Digital Technologies
The Pharmaceutical Analysis and Digital Technologies (PADT) team has an opening for a Principal Scientist to serve as Strategy Lead for our Cleaning Verification Center of Excellence (CoE), based in Rahway, NJ.
In this role, the Principal Scientist will define and lead the strategy for the Cleaning Verification CoE, establishing harmonized, science- and risk-based approaches to cleaning verification across all modalities in our clinical portfolio, including small molecule (e.g., oral solid dosage forms and sterile liquids) and large molecule programs. The Strategy Lead will drive the development, validation, and lifecycle management of cleaning verification methods and practices, ensuring cGMP compliance, operational excellence, and a sustained state of inspection readiness. The Principal Scientist should be engaged with regulatory and industry trends, including health-based exposure limits (HBELs), and have thorough working knowledge of cGMPs, ICH, and relevant FDA and global health authority expectations for cleaning verification and validation.
In addition, the Strategy Lead will partner with Analytical leadership, extended leadership teams, and cross-functional stakeholders in Process Engineering, Clinical Manufacturing, and Quality and to identify and advance key departmental strategic and cultural initiatives. As the recognized subject matter expert, the Principal Scientist will mentor scientists and build cleaning verification capability across the organization through training, knowledge sharing, and coaching. The role will also be responsible for proactive resource planning, risk assessment strategies, and continuous improvement of CoE processes, standards, and tools.
Primary Responsibilities
Essential knowledge and responsibilities include:
- Technical expertise in analytical methodologies applied to cleaning verification for both small and large molecules, such as liquid chromatography, total organic carbon (TOC), spectroscopy, and conductivity, including swab/rinse sampling and recovery studies.
- Define and execute the Cleaning Verification CoE strategy and roadmap, including harmonized standards, best practices, and governance across programs and sites.
- Lead the development, validation, and transfer of cleaning verification methods to enable on-time, right first-time equipment release for clinical manufacture of drug substance and drug product.
- Partner with Process Engineering, Clinical Manufacturing, and Quality to establish science- and risk-based cleaning acceptance limits across small and large molecule modalities (e.g., HBEL-based carryover calculations).
- Provide technical and compliance oversight on cleaning-related lab investigations and deviations including root cause analysis and identification of robust corrective and preventative actions.
- Review and approval of cleaning verification data, protocols, technical reports, and SOPs.
- Serve as the cleaning verification subject matter expert during internal and external compliance audits and regulatory inspections.
- Drive operational excellence, innovation, and process improvements, including evaluation and implementation of new analytical technologies and digital tools.
- Technical mentorship and development of scientists, building cleaning verification capability across the organization.
- Cross-functional leadership and influence, including working with senior management to drive departmental strategic and cultural initiatives.
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·
- Proven technical leadership in analytical cleaning verification and/or validation, ideally in a GMP setting; experience with both small and large molecules preferred.
- Track record of shaping and delivering strategy and influencing without direct authority in a matrixed organization.
- In-depth knowledge of cGMP, ICH, FDA, and global health authority expectations for cleaning verification and validation.
- Excellent scientific communication skills and a creative, collaborative approach.
- Strong coaching and interpersonal skills, with the ability to work effectively in cross-functional teams.
#AR&D
Required Skills:
Analytical Chemistry, Analytical Method Development, Assay Development, Bioanalytical Analysis, Biochemistry, Cleaning Validations, Clinical Judgment, Drug Launches, Liquid Chromatography (LC), Matrix Leadership, Method Validation, Pharmaceutical Industry, Pharmaceutical Sciences, Regulatory Inspections, Small Molecules
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.
Additional location(s) Compensation Information:
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not Applicable
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
12/11/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
