Principal Scientist, Cleaning Verification Center of Excellence Strategy Lead, Pharmaceutical Analysis and Digital Technologies

Job description

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: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts 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