Senior Scientist, Engineering
Merck
13 days ago
On-site
Rahway, NJ
Operations
Responsibilities:
- Work on a project team for process characterization, technology transfer, and validation of biopharmaceutical molecules with line-of-sight for licensure and commercialization.
- Plan and/or execute scale studies to support commercial process validation, process characterization, and investigation evaluations (in-house and/or externally).
- Design, plan, and execute laboratory experiments to generate high-quality data; analyze data; report results via presentations and technical reports.
- Collaborate with commercial manufacturing teams; support facility start-up and on-the-floor support for drug substance manufacturing (in-house and at CMOs).
- Provide technical leadership for trends in process monitoring (SPC/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 assignment execution against accelerated, critical-path timelines in a right-first-time manner.
Qualifications (Required):
- Experience in large molecule process development, including scaling (up/down) and tech transfer of drug substance processes.
- Upstream lab scale execution experience, DOE, statistical data analysis, and presentation of results.
- Experience authoring technical documentation supporting regulatory submissions for product licensure.
- Strong communication and people skills; ability to mentor and develop SMEs.
- Working knowledge of analytical methods for large molecules; US/EU regulatory requirements; cGMP principles/regulations.
Qualifications (Preferred):
- Hands-on mammalian cell culture (bench scale) and high-throughput bioreactors (e.g., 2L, 3L, Ambr250).
- On-the-floor GMP manufacturing support and batch record review/operations knowledge.
- Modeling (scaling calculations, CFD), QbD, Lean Six Sigma.
- Experience supporting/writing regulatory filings (IND, MAA, BLA) and inspections (FDA, EMA, JNDA, TGA).
Education:
- Bachelor’s (6 years relevant), or Master’s (4 years relevant), or PhD in Chemical/Bio/Biological Engineering.
Application:
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline stated on posting.
Requisition ID: R399742
- Work on a project team for process characterization, technology transfer, and validation of biopharmaceutical molecules with line-of-sight for licensure and commercialization.
- Plan and/or execute scale studies to support commercial process validation, process characterization, and investigation evaluations (in-house and/or externally).
- Design, plan, and execute laboratory experiments to generate high-quality data; analyze data; report results via presentations and technical reports.
- Collaborate with commercial manufacturing teams; support facility start-up and on-the-floor support for drug substance manufacturing (in-house and at CMOs).
- Provide technical leadership for trends in process monitoring (SPC/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 assignment execution against accelerated, critical-path timelines in a right-first-time manner.
Qualifications (Required):
- Experience in large molecule process development, including scaling (up/down) and tech transfer of drug substance processes.
- Upstream lab scale execution experience, DOE, statistical data analysis, and presentation of results.
- Experience authoring technical documentation supporting regulatory submissions for product licensure.
- Strong communication and people skills; ability to mentor and develop SMEs.
- Working knowledge of analytical methods for large molecules; US/EU regulatory requirements; cGMP principles/regulations.
Qualifications (Preferred):
- Hands-on mammalian cell culture (bench scale) and high-throughput bioreactors (e.g., 2L, 3L, Ambr250).
- On-the-floor GMP manufacturing support and batch record review/operations knowledge.
- Modeling (scaling calculations, CFD), QbD, Lean Six Sigma.
- Experience supporting/writing regulatory filings (IND, MAA, BLA) and inspections (FDA, EMA, JNDA, TGA).
Education:
- Bachelor’s (6 years relevant), or Master’s (4 years relevant), or PhD in Chemical/Bio/Biological Engineering.
Application:
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline stated on posting.
Requisition ID: R399742