Associate Principal Scientist, Engineering- Cell ...

OverviewWe are seeking a strategic and technical leader with expertise in cell culture commercialization. The Biologics Drug Substance Commercialization (BDSC), Cell Culture Sciences department, provides the technical leadership and laboratory capabilities in support of late-stage pipeline commercialization and post-market commercial manufacturing support. BDSC supports stage 1 & 2 process validation deliverables (2011 FDA process validation guidance) including pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal and external manufacturing sites, manufacturing investigations, process validation, second generation process development and authoring of regulatory submissions.Under the general scientific and administrative direction of the Director in Biologics Cell Culture Sciences group and in collaboration with internal and external partners, this role supports late-stage and commercial large molecule biologics program activities. The individual leads a team to support development activities and commercialization activities of late-stage pipeline and/or post-market commercial manufacturing biologics, including site-to-site process transfers, manufacturing investigations and trend evaluations, process enhancements, next generation process development and characterization, process validation, and regulatory submission authoring.ResponsibilitiesCoordinate project planning, resourcing, progress reporting, troubleshooting and people management.Serve as the scientific/technical mentor for junior staff. Provide technical guidance in the various aspects of cell culture process development/commercialization for large molecule products.Responsible for process development, process characterization and regulatory filing activities to ensure a smooth and clear path to successful PPQs and BLAs for the company’s pipeline.Manage large multifaceted projects as the leader of a cross-functional team.Ensure project results meet requirements regarding technical quality, reliability, schedule, and cost.Monitor performance and recommend schedule changes, cost adjustments or resource additions.Solve technical and non-technical problems throughout the life of the project, and resolve issues during design and planning phases whenever possible.Provide timely and accurate information and status updates to project sponsors and management.May be responsible for managing large multifaceted projects as the leader of a cross-functional team.Champion compliance and safety; promote a culture of diversity, inclusion, and equity.Education and ExperienceBachelor’s degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with eight (8) years of relevant industry experienceOR Master’s degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with six (6) years of relevant industry experienceOR Ph.D. in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with four (4) years of relevant industry experienceRequired Experience and SkillsStrong fundamental knowledge and subject matter expertise with mammalian cell culture processing of biologics (large molecule products), recent advances, and challenges in the fieldExpertise in independently conducting and directing the planning, execution, analysis, and documentation of all stages of cell culture process commercialization.Experience with late-stage commercial process development (CPD), technology transfer (TT), scale-down model qualification (SDMQ) and process characterization (PC).Experience authoring technical documentation in support of process characterization (PC), process performance qualification (PPQ), risk assessment (RA), control strategy, process comparability reports, and/or regulatory submissions (BLA/MAA/JNDA etc.).Adaptability and agility to prioritize and deliver complex objectives, often on tight timelines, in a rapidly changing environment.Experience and aptitude to lead, work, and collaborate in internal and external cross-functional, matrixed teams.Action-oriented mindset for creativity; ability to take initiative, innovate, iterate, and problem-solve.Demonstrated commitment and experience to coach and mentor staff to maximize talent development and utilization.Excellent interpersonal and communication skillsPreferred Experience and SkillsExperience in leadership of CMC development teams.Experience with cell culture process development for biologics.Experience with high throughput microbioreactor systems, and advanced in situ analytics for process monitoring and controlExperience with state-of-the-art cell culture processes including intensified inoculum/fed-batch and perfusion process development.Background in data science approaches related to cell culture and predictive modeling (e.g., MFA, omics, machine learning; experience integrating PAT efforts).Experience with on-the-floor GMP manufacturing support, familiarity with manufacturing batch record reviews and/or operations.Experience with mathematical modeling, theoretical scaling calculations, drug substance comparability, scale-down establishment, CFD modeling, QbD and Lean Six Sigma principles.Experience supporting/writing regulatory filings (IND, MAA, BLA) and inspections with multiple agencies (FDA, EMA, JNDA, TGA).Additional DetailsUS and Puerto Rico Residents Only: Our company is committed to inclusion; please request accommodations during the application or hiring process if needed.US law requires Equal Employment Opportunity statements. We are an Equal Employment Opportunity Employer 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 protected characteristics. We comply with applicable affirmative action requirements where required by law.Hybrid work model: U.S. based employees in office roles will follow a Hybrid schedule (three on-site days per week, with Friday remote) unless business needs require otherwise.Salary range: $139,600.00 - $219,700.00. Eligible for annual bonus and long-term incentive, if applicable.Benefits include medical, dental, vision, retirement plans, paid holidays, vacation, and sick days. More information is available on the company benefits page.Application link: Merck careers — apply via /us/enSan Francisco and Los Angeles residents: applicable local laws on fair chance hiring apply.Posting end date: 09/19/2025. Please apply by the day before the end date. #J-18808-Ljbffr

Created: 2025-09-21