Job DescriptionJob Title: Senior Scientist, Cell Culture Sciences, Biologics Drug Substance CommercializationLevel: R3Location: Rahway, NJ (primary)Key Responsibilities:- Technical Strategy: Deliver robust DS strategies for successful commercialization. Provide technical oversight of cell culture 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.
- Technical knowledge: Fundamental knowledge and subject matter expertise with mammalian cell culture processing of biologics (large molecule products), recent advances, and challenges in the field. Experience in independently conducting and directing the planning, execution, analysis, and documentation of all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions.
- CMC RA: Experience supporting/writing regulatory filings (IND, MAA, BLA) and supporting inspections with multiple agencies (FDA, EMA, JNDA, TGA).
- Leadership: Support Cell Culture CMC teams, and align resources to deliver on priorities. Mentor a team of scientists specializing in biologics commercialization, serving as the scientific/technical mentor for junior staff. Action-oriented, mindset for creativity; ability to take initiative, innovate, iterate, and problem-solve.
- Cross-Functional Collaboration: Unite diverse teams to achieve program goals as One Team. Champion compliance and safety; promote a culture of diversity, inclusion, and equity. Experience and aptitude to work, and collaborate in internal and external cross-functional, matrixed teams.
- Problem Solving: Remove roadblocks, resolve conflicts, and escalate issues when needed.
- Communication: Foster collaboration, ensure transparency, and engage with governance bodies.Excellent interpersonal and communication skills
- Project Management: Adaptability and agility to prioritize and deliver complex objectives, often on tight timelines, in a rapidly changing environment.
- Recognition: Celebrate team achievements and foster a culture of appreciation.
- Innovation: Lead business improvement initiatives and leverage your network to drive change.
Education & Experience:- Bachelor's degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with six (6) years of relevant industry experience. OR
- Master's degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with four (4) years of relevant industry experience. OR
- Ph.D. in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with a no minimum relevant knowledge.
What You Bring:- Expertise in cell culture commercialization and manufacturing operations
- Understanding of regulatory requirements
- Ability to lead without authority, build trust, and inspire accountability
- Ethical, resilient, and committed to excellence
- Skilled in risk management, team facilitation, and strategic planning
- Experience in commercial manufacturing and CMC development
- Exceptional communication and stakeholder engagement skills
Required Skills: Adaptability, Adaptability, Biological Engineering, Biomanufacturing, Bioreactors, Cell Cultures, cGMP Regulations, Chemical Engineering, Chromatographic Techniques, Clinical Judgment, Cross-Functional Collaboration, Design of Experiments (DOE), Detail-Oriented, Good Manufacturing Practices (GMP), Mammalian Cell Culture, Process Design, Process Optimization, Process Scale Up, Process Validation, Risk Analysis, Risk Assessments, Risk Control Assessment, Small Molecule Synthesis, Stakeholder Communications, Stakeholder Engagement {+ 1 more}
Preferred Skills: Current Employees apply HERECurrent Contingent Workers apply HERESan 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:Domestic
VISA Sponsorship:No
Travel Requirements:10%
Flexible Work Arrangements:Not Applicable
Shift:Not Indicated
Valid Driving License:No
Hazardous Material(s):n/a
Job Posting End Date:06/23/2026
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