Associate Principal Scientist, Biologics Process R&D
Merck
12 days ago
Remote friendly (Rahway, NJ)
United States
Clinical Research and Development
Position Summary
Associate Principal Scientist (Cell Line Development). Provide scientific/technical leadership for late-stage biologics programs focused on cell line development and cell banking regulatory strategy, filing authoring, and health authority response support. Ensure cell line development and cell bank characterization data packages support global regulatory submissions; interface with Cell Line Development, Regulatory CMC, and cross-functional CMC teams.
Key Responsibilities
- Lead/support cell line development and cell bank characterization for late-stage biologics.
- Design/execute pre-LIVCA studies; coordinate LIVCA campaigns; generate genetic stability data to support control strategy for commercial manufacturing (partner with Upstream, Downstream, Analytical, and Manufacturing).
- Author/review CLD sections of IND, IMPD, BLA, MAA submissions; support responses to global regulators.
- Serve as CLD representative on cross-functional CMC teams; partner with Regulatory CMC on filing strategies.
- Support RTQs on cell line development/banking, clonality, genetic stability, LIVCA, and control strategy.
- Author technical reports, source documents, risk assessments, and knowledge management; support digitization.
Required Qualifications
- Ph.D. in relevant discipline with 4+ years industry experience, or Master’s with 8+ years.
- Mammalian cell line development experience (preferably CHO-based therapeutic protein/monoclonal antibody systems).
- Working knowledge of ICH guidelines and regulatory expectations (cell substrates, cell banking, genetic stability).
- Late-stage biologics support incl. pre-LIVCA phenotypic/genotypic stability packages.
- Experience authoring CLD-related regulatory submissions and RTQs.
- Strong scientific writing/communication.
- Deep knowledge of cell line history, clone selection, clonality, cell substrate characterization, bank generation/testing, genetic stability, LIVCA.
- Independent, able to manage multiple priorities and influence cross-functional teams.
Preferred Qualifications
- Global regulatory submission experience (US, Europe, Japan, China).
- Upstream commercial process development experience.
- Hands-on genetic characterization (RNAseq, PCR, Southern/Northern blotting).
- Source documents/technical summaries/RTQs/briefing materials.
- Early-to-late-stage experience connecting CLD decisions to long-term strategy.
Application Instructions
Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub as a current employee). Job posting end date: 06/6/2026 (effective until 11:59:59PM the day before).
Associate Principal Scientist (Cell Line Development). Provide scientific/technical leadership for late-stage biologics programs focused on cell line development and cell banking regulatory strategy, filing authoring, and health authority response support. Ensure cell line development and cell bank characterization data packages support global regulatory submissions; interface with Cell Line Development, Regulatory CMC, and cross-functional CMC teams.
Key Responsibilities
- Lead/support cell line development and cell bank characterization for late-stage biologics.
- Design/execute pre-LIVCA studies; coordinate LIVCA campaigns; generate genetic stability data to support control strategy for commercial manufacturing (partner with Upstream, Downstream, Analytical, and Manufacturing).
- Author/review CLD sections of IND, IMPD, BLA, MAA submissions; support responses to global regulators.
- Serve as CLD representative on cross-functional CMC teams; partner with Regulatory CMC on filing strategies.
- Support RTQs on cell line development/banking, clonality, genetic stability, LIVCA, and control strategy.
- Author technical reports, source documents, risk assessments, and knowledge management; support digitization.
Required Qualifications
- Ph.D. in relevant discipline with 4+ years industry experience, or Master’s with 8+ years.
- Mammalian cell line development experience (preferably CHO-based therapeutic protein/monoclonal antibody systems).
- Working knowledge of ICH guidelines and regulatory expectations (cell substrates, cell banking, genetic stability).
- Late-stage biologics support incl. pre-LIVCA phenotypic/genotypic stability packages.
- Experience authoring CLD-related regulatory submissions and RTQs.
- Strong scientific writing/communication.
- Deep knowledge of cell line history, clone selection, clonality, cell substrate characterization, bank generation/testing, genetic stability, LIVCA.
- Independent, able to manage multiple priorities and influence cross-functional teams.
Preferred Qualifications
- Global regulatory submission experience (US, Europe, Japan, China).
- Upstream commercial process development experience.
- Hands-on genetic characterization (RNAseq, PCR, Southern/Northern blotting).
- Source documents/technical summaries/RTQs/briefing materials.
- Early-to-late-stage experience connecting CLD decisions to long-term strategy.
Application Instructions
Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub as a current employee). Job posting end date: 06/6/2026 (effective until 11:59:59PM the day before).