Senior Scientist, Engineering
Merck
12 days ago
On-site
West Point, PA
Operations
Process Development Scientist
Responsibilities:
- Work on project teams for process characterization, technology transfer, and validation of biopharmaceutical molecules with line-of-sight for licensure and commercialization.
- Plan or execute scale studies to support commercial process validation, process characterization, and investigation evaluations (in-house or externally).
- Design, plan, and execute laboratory experiments; perform data analysis; communicate results via presentations and technical reports.
- Collaborate with commercial manufacturing teams to support facility start-up and provide on-the-floor support for drug substance manufacturing (including at CMOs).
- Provide technical leadership for interpretations of commercial process monitoring trends (SPC and/or MVA); lead technical investigations and process changes to improve yield and/or robustness.
- Author regulatory and technical documentation for process tech transfer and validation; support regulatory queries and inspections.
- Lead execution against accelerated, critical-path timelines in a right-first-time manner.
Qualifications:
Required:
- Experience in large-molecule process development, including scaling and tech transfer of drug substance processes.
- Upstream lab scale execution, DOE, statistical data analysis, and presenting results.
- Experience authoring technical documentation for regulatory submissions leading to product licensure.
- Strong communication and people skills; ability to mentor/coaching and develop SMEs.
- Working knowledge of analytical methods for large molecules, US/EU regulatory requirements, and cGMP principles/regulations.
Preferred:
- Hands-on mammalian cell culture and high-throughput bioreactor experience (e.g., 2L, 3L, Ambr250) with lab leadership.
- On-the-floor GMP manufacturing support; familiarity with batch record reviews/operations.
- Expertise in mathematical modeling/scaling calculations, CFD, QbD, Lean Six Sigma.
- Support/writing regulatory filings (IND, MAA, BLA) and inspections (FDA, EMA, JNDA, TGA).
Education & Experience:
- Bachelor’s degree (Chemical/Bioengineering or related) + 6 years; OR Master’s + 4 years; OR Ph.D. (no minimum).
Required skills:
Adaptability; Biodesign; Cell cultures; cGMP regulations; chromatography techniques; cross-functional collaboration; DOE; detail-oriented; GMP; mammalian/primary cell culture; process characterization/design/optimization/scale-up; project & risk management; stakeholder communications; strategic planning; technology transfer.
Preferred skills:
- Current Employees apply HERE; Current Contingent Workers apply HERE.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Apply by the stated deadline on the posting.
Responsibilities:
- Work on project teams for process characterization, technology transfer, and validation of biopharmaceutical molecules with line-of-sight for licensure and commercialization.
- Plan or execute scale studies to support commercial process validation, process characterization, and investigation evaluations (in-house or externally).
- Design, plan, and execute laboratory experiments; perform data analysis; communicate results via presentations and technical reports.
- Collaborate with commercial manufacturing teams to support facility start-up and provide on-the-floor support for drug substance manufacturing (including at CMOs).
- Provide technical leadership for interpretations of commercial process monitoring trends (SPC and/or MVA); lead technical investigations and process changes to improve yield and/or robustness.
- Author regulatory and technical documentation for process tech transfer and validation; support regulatory queries and inspections.
- Lead execution against accelerated, critical-path timelines in a right-first-time manner.
Qualifications:
Required:
- Experience in large-molecule process development, including scaling and tech transfer of drug substance processes.
- Upstream lab scale execution, DOE, statistical data analysis, and presenting results.
- Experience authoring technical documentation for regulatory submissions leading to product licensure.
- Strong communication and people skills; ability to mentor/coaching and develop SMEs.
- Working knowledge of analytical methods for large molecules, US/EU regulatory requirements, and cGMP principles/regulations.
Preferred:
- Hands-on mammalian cell culture and high-throughput bioreactor experience (e.g., 2L, 3L, Ambr250) with lab leadership.
- On-the-floor GMP manufacturing support; familiarity with batch record reviews/operations.
- Expertise in mathematical modeling/scaling calculations, CFD, QbD, Lean Six Sigma.
- Support/writing regulatory filings (IND, MAA, BLA) and inspections (FDA, EMA, JNDA, TGA).
Education & Experience:
- Bachelor’s degree (Chemical/Bioengineering or related) + 6 years; OR Master’s + 4 years; OR Ph.D. (no minimum).
Required skills:
Adaptability; Biodesign; Cell cultures; cGMP regulations; chromatography techniques; cross-functional collaboration; DOE; detail-oriented; GMP; mammalian/primary cell culture; process characterization/design/optimization/scale-up; project & risk management; stakeholder communications; strategic planning; technology transfer.
Preferred skills:
- Current Employees apply HERE; Current Contingent Workers apply HERE.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Apply by the stated deadline on the posting.