{"id":3669773,"url":"https://alion.io/job/merck-co-principal-scientist-upstream-process-development-2","title":"Principal Scientist, Upstream Process Development","company":{"id":3768,"name":"Merck & Co.","domain":"msd.com","url":"https://alion.io/company/msd","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":98,"open_postings":143,"ghost_share":0.035,"stale_share":0.119,"repost_share":0.154,"time_to_fill_p50_days":16,"computed_at":"2026-11-03T05:54:40Z"}},"role":"Science & Research","role_family":"Science & Research","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Rahway, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":173200,"max":272600,"currency":"USD","period":"year","gross":null,"usd_annual":272600},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Bioreactors","optional":false},{"name":"Cell Culture","optional":false},{"name":"Machine Learning","optional":true}],"status":"live","first_seen_at":"2026-11-03T08:52:40Z","employer_posted_date":"2026-11-03","last_verified_at":"2026-11-04T01:49:58Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"Job Description\nThe Biologics Process Research & Development organization within our Company's Research Labs is responsible for developing the drug substance manufacturing processes for our Company's biologics pipeline. We work closely with colleagues in Discovery, Pre-clinical and Early Development to rapidly develop manufacturing processes for varied biotherapeutics and efficiently manufacture material to supply clinical trials. We are also responsible for late-stage process development and process characterization to prepare for commercial manufacturing. We work with our partners in our Company Manufacturing Division to commercialize and launch new products.\nWe are seeking a highly motivated and experienced individual to join our team as a Principal Scientist. In this role, the successful candidate will lead cross-functional teams to develop CMC packages for our pipeline assets. The successful candidate will also collaborate with fellow Bioprocess Development colleagues to develop and refine technical strategy related to next generation processing for assets in early- and late-stage clinical development. Applicants must have effective organizational and multi-tasking skills, demonstrated excellent scientific leadership, and superior written and oral communications abilities. A track record of leveraging data science and digital tools for delivering impactful solutions to complex problems are distinguishing. Evidence of strong cross-functional collaboration, experience successfully mentoring junior scientist, leading projects, and strong external presence through scientific excellence are expected.\nJOB RESPONSIBILITIES:\nThe successful candidate will contribute to CMC development of our Company's pipeline, playing an active role in development of cell culture processes and transfer to clinical and commercial manufacturing sites. They will also develop strategies for process and pipeline-facing innovation. Responsibilities include:\nLeading biologic upstream process development for first-in-human and commercial processes by efficiently developing high yield, robust and scalable cell culture processes.\nProviding technical direction for process development, characterization, commercialization, and regulatory filing activities to ensure a smooth and clear path to successful PPQs an BLAs for our company pipeline.\nAdvancing upstream platform process technical strategy and championing creative process improvement initiatives\nInitiating new collaborations to assess new technologies and industry strategies with relevance to our Company.\nCollaborating with academia, industry partners, and vendors to drive development, innovation and adoption of new process technologies with broad impact to projects or platform.\nKeeping current with the external patent and literature environment; actively presents and publishes externally and pursues patenting strategies.\nMentoring and educating junior scientists\nMinimum education required:\nPh.D. with 6+ years of industry experience or Master with 8+ years industry experience in Chemical Engineering, Bioengineering, Biochemistry or a related field.\nRequired experience and skills:\nMentoring and educating junior scientists\nProven record of accomplishments in upstream process and technology development with a strong scientific publication and presentation track record.\nExperience in CHO fed-batch cell culture and a working understanding of downstream & analytics.\nUnderstanding and hands-on experience on cell culture bioreactors including microbioreactors, bench-scale and pilot-scale bioreactors, and scaleup/tech transfer activities.\nWorking knowledge of cell culture media, CHO cell biology and metabolism, DOE statistics and computational fluid dynamics.\nAbility to direct the planning, execution, analysis, and documentation of all stages of cell culture process development.\nAbility to work in a matrixed team environment and collaborate with both internal and external partners including vendors.\nKnowledge of biologics CMC development cycle.\nExperience with late-stage commercial process development, technology transfer, scale-down model qualification and process characterization.\nDemonstrated ability for taking initiative, creativity, and innovation in problem solving.\nDemonstrated ability to develop staff to maximize utilization of talent and actively guides career development; builds strong and collaborative teams.\nPreferred experience and skills:\nExperience with state-of-the-art cell culture processes including intensified inoculum and perfusion process development.\nExperience with high throughput microbioreactor systems, and advanced in situ analytics for process monitoring and control.\nExpertise in media development, media/solution chemistry.\nBackground in data science approaches related to cell culture and predictive modeling e.g., metabolic flux analysis (MFA), omics, machine learning; experience integrating PAT efforts) and computational fluid dynamics (CFD).\nExperience leading cross functional, program development teams.\nRequired Skills:\nBiologics, Bioreactors, Biotherapeutics, Cell Culture Process Development, Cell Line Development, Combination Products, Computational Fluid Dynamics (CFD), Finite Element Analysis (FEA), Pharmaceutical Process Development, Process Characterization, Process Development (PD), Product Development Lifecycle, Regulatory Filings, Technology TransferPreferred Skills:\nCurrent Employees apply HERE\nCurrent Contingent Workers apply HERE\nUS and Puerto Rico Residents Only:\nOur 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.\nAs 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. Asa 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:\nEEOC Know Your Rights\nEEOC GINA Supplement\nWe 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.\nLearn more about your rights, including under California, Colorado and other US State Acts\nThe primary location for this posting is:\nUSA - New Jersey - RahwayWhere required by law, the compensation range for this role is provided below.\nThe salary range for the primary location of this role is:\n$173,200.00 - $272,600.00This 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.\nWe 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.\nAdditional 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.\nAdditional location(s) Compensation Information:\nSan Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance\nLos 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\nSearch Firm Representatives Please Read Carefully\nMerck & 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.\nEmployee Status:\nRegularRelocation:\nDomesticVISA Sponsorship:\nYesTravel Requirements:\n10%Flexible Work Arrangements:\nNot ApplicableShift:\nNot IndicatedValid Driving License:\nNoHazardous Material(s):\nn/aJob Posting End Date:\n11/28/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. 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