Senior Scientist, Engineering- Cell Banking
Merck
September 03, 2026
Remote friendly (West Point, PA)
United States
Operations
Responsibilities:
- Support mid-late stage and commercial cell bank projects for large molecule programs; manage commercialization activities for late-stage pipeline and/or post-market working cell banks for biologics/vaccines.
- Lead cell bank process risk assessments, documentation, process characterization, technology transfer, and qualification of new cell banks (for licensure/commercialization).
- Plan and execute work to support working cell bank commercialization; identify/implement process changes (replenishment lots, control strategies), evaluate investigations/trends, and support regulatory filings.
- Design and execute laboratory experiments; analyze data; communicate results via presentations and technical reports.
- Collaborate with internal teams and CMOs; deliver process documentation packages, review batch records, and provide investigation support.
- Author regulatory/technical documentation for cell bank transfer, long-term storage stability, qualification, and licensure; support regulatory queries/inspections.
- Provide technical leadership and drive standardization of best practices across the network; execute assignments on accelerated timelines with safety/compliance focus.
Minimum Required Education/Experience:
- Bachelor’s + 5 years cell culture experience in pharma; OR Master’s + 3 years; OR Ph.D. with no industry experience.
Required Expertise/Skills:
- Cell line development and cell culture metabolism/death/media adaptation.
- Hands-on mammalian/microbial cell culture (adherent/suspension), including enumeration/expansion, virus infection, cryopreservation, cell bank prep, lab operations.
- Upstream lab execution, DOE, statistical analysis, strong communication and problem-solving, project management.
Preferred Expertise/Skills:
- Large molecule process development; US/EU regulatory and cGMP; authoring regulatory documents; bench lead/team oversight; GMP manufacturing support and batch record reviews.
- QbD, Lean Six Sigma; filings/inspections (IND/MAA/BLA).
Compensation/Benefits (if applicable/explicit):
- Salary range: $117,000.00–$184,200.00; eligible for annual bonus and long-term incentive (if applicable). Comprehensive benefits include medical/dental/vision, 401(k), paid holidays/vacation, and sick/compassionate days.
Application Instructions:
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub if internal). Application deadline is listed on the posting.
- Support mid-late stage and commercial cell bank projects for large molecule programs; manage commercialization activities for late-stage pipeline and/or post-market working cell banks for biologics/vaccines.
- Lead cell bank process risk assessments, documentation, process characterization, technology transfer, and qualification of new cell banks (for licensure/commercialization).
- Plan and execute work to support working cell bank commercialization; identify/implement process changes (replenishment lots, control strategies), evaluate investigations/trends, and support regulatory filings.
- Design and execute laboratory experiments; analyze data; communicate results via presentations and technical reports.
- Collaborate with internal teams and CMOs; deliver process documentation packages, review batch records, and provide investigation support.
- Author regulatory/technical documentation for cell bank transfer, long-term storage stability, qualification, and licensure; support regulatory queries/inspections.
- Provide technical leadership and drive standardization of best practices across the network; execute assignments on accelerated timelines with safety/compliance focus.
Minimum Required Education/Experience:
- Bachelor’s + 5 years cell culture experience in pharma; OR Master’s + 3 years; OR Ph.D. with no industry experience.
Required Expertise/Skills:
- Cell line development and cell culture metabolism/death/media adaptation.
- Hands-on mammalian/microbial cell culture (adherent/suspension), including enumeration/expansion, virus infection, cryopreservation, cell bank prep, lab operations.
- Upstream lab execution, DOE, statistical analysis, strong communication and problem-solving, project management.
Preferred Expertise/Skills:
- Large molecule process development; US/EU regulatory and cGMP; authoring regulatory documents; bench lead/team oversight; GMP manufacturing support and batch record reviews.
- QbD, Lean Six Sigma; filings/inspections (IND/MAA/BLA).
Compensation/Benefits (if applicable/explicit):
- Salary range: $117,000.00–$184,200.00; eligible for annual bonus and long-term incentive (if applicable). Comprehensive benefits include medical/dental/vision, 401(k), paid holidays/vacation, and sick/compassionate days.
Application Instructions:
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub if internal). Application deadline is listed on the posting.