Principal Scientist, Engineering - Sterile Drug Product Commercialization, Biologics

Job Summary As part of Our Company’s Manufacturing Division, the Sterile Drug Product Commercialization group provides the technical process leadership and laboratory capabilities for late stage and commercial drug product processes for biologics. It is the division’s leader in sterile product and process development, responsible for late-stage commercialization activities including process scale up, technology transfer to internal and external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations. The group is responsible for establishing the science, engineering and knowledge required for today’s innovative and accelerated commercialization of biologics and combination products. We are seeking an experienced Principal Scientist to advance and commercialize biologics pipeline programs. As a member of the drug product team, the Principal Scientist will have a key focus on driving excellence in process characterization, scale up, transfer and process validation activities. Accountabilities and Responsibilities Execute and provides oversight to biologics product and process design, development, characterization, technology transfer, and robust commercial validation Leads and/or serves on cross functional biologics drug product (DP) working groups and manages DP activities through filing and Process Performance Qualification (PPQ), including registration stability study execution, process characterization plan and execution, tech transfer control strategy, process development, PPQ readiness, PAI (Pre‑Approval Inspection) readiness, approval, launch and post‑launch support. Ensures commercialization programs meet requirements related to science, quality, reliability, schedule, and cost. Drives strategic initiatives (technical and/or business process related) in the department and with partner groups, that enable more efficient and rapid commercialization of innovative products Provides mentorship, technical oversight and strategic guidance to employees. Uses advanced experience gained on scientific/technical issues to guide others to address non routine and/or difficult issues. Develops a process and product development plan. Influences decisions related to primary packaging and combination product design. Responsible for the design and execution of DP development and commercialization studies, new product introduction and process validation at commercial sites. Ensures fit‑for‑purpose scale‑down models are developed and employed. Establishes and validates platform engineering and scientific models for sterile product and process commercialization. Innovates and drives best practices for commercial site tech transfer, facility fit and development of the DP control strategy. Includes the classification of process parameters, performance parameters, operating ranges, in‑process controls. Drives and influences process demonstration and qualification (PPQ) and shelf‑life strategies. Influences CMC regulatory strategy and is accountable for DP CMC sections of filing. Reviews regulatory strategy and filing readiness and supports preparations for agency meetings. Authors and reviews regulatory submissions. Drives continuous and phase appropriate process optimization towards standardized platforms for liquid, lyophilized, and combination product presentations. Establishes and fosters a culture of high performance, out of the box thinking, innovation and learning, empowerment. Position Qualifications Education Minimum Requirements: B.S. in Chemical Engineering, Biochemical Engineering Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 12 years of relevant experience; or Master's degree in chemical engineering, Biochemical Engineering Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 10 years of relevant experience; or Ph.D. in Chemical Engineering, Biochemical Engineering Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 8 years of relevant experience Required Experience and Skills Experience with drug product process development, optimization, and/or process characterization of biologics (mAbs, ADCs and/or fusion proteins) Experience with at scale biologics drug product manufacturing and fill finish operations Experience with late‑stage commercialization of biologics programs Technical expertise in sterile drug product fill finish related manufacturing processes for large molecules, including laboratory and/or fundamental models for key unit operations. Experience with technology transfer and scale‑up of processes to pilot and/or manufacturing scales. Excellent oral and written communication skills. Ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc, in a multi‑disciplinary team environment Preferred Experience and Skills Operations experience in the manufacturing of potent and sterile drug products, at pilot and/or commercial scale. Experience with commercialization of biologics programs through PPQ and launch Working knowledge in analytical methods and product attributes for biologics Working knowledge of regulatory requirements for commercialization and registration of sterile drug products, including application of Quality by Design principles Working knowledge of current Good Manufacturing Practices (cGMPs) for manufacturing of sterile dosage forms and current ICH Quality norms, as applied in Manufacturing Science and Technology or Technical Operations. Working knowledge of statistical methods for DOE design and data analysis, statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for manufacturing processes Experience in Data Analytics, Computer Modeling, and Digital Applications. Working understanding of analytical methods to characterize biologics and other sterile drug products US and Puerto Rico Residents Only The primary location for this posting is: USA - Pennsylvania - West Point. Where required by law, the compensation range for this role is provided below. The salary range for the primary location of this role is: $173,200.00 - $272,600.00 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. Benefits 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 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. Other Information Employee Status: Regular Relocation: Domestic VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 10/27/2026 *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. Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. #J-18808-Ljbffr MSD