Associate Principal Scientist, Biologics Development
Merck
August 25, 2026
On-site
Rahway, NJ
Clinical Research and Development
Why You’ll Love This Role:
- As a Biologics Cell Culture Commercialization Leader, provide strategic and tactical technical direction through cross-functional partnerships with key business units and customers.
- Support DS commercialization: process characterization, control strategy development, tech transfer to internal/external manufacturing sites, process validation, second-generation process development, and health authority licensure.
Key Responsibilities:
- Technical Strategy: deliver robust DS strategies; provide technical oversight of cell culture process development, process characterization, and regulatory filing activities to support PPQs and BLAs.
- Technical Leadership: mammalian cell culture processing expertise; independently plan, execute, analyze, and document commercialization stages; lead risk assessment, control strategies, process comparability reports, PPQ, and regulatory submissions.
- CMC Regulatory Affairs: support/writing regulatory filings (IND, MAA, BLA) and inspections with agencies (FDA, EMA, JNDA, TGA).
- Leadership: establish/manage cell culture CMC teams; align resources; mentor scientists.
- Cross-Functional Collaboration: lead in internal/external matrix teams; champion compliance and safety.
- Problem Solving: remove roadblocks, resolve conflicts, escalate as needed.
- Communication & Project Management: ensure transparency; drive schedules, priorities, and performance metrics.
- Innovation: lead business improvement initiatives.
Education & Experience:
- BS (Chem/Bioengineering or related) + 8 years industry experience OR MS + 6 years OR PhD + 3 years.
Required Experience:
- Proven leadership in biologics development/commercialization; deep expertise in cell culture commercialization and manufacturing operations; strong regulatory understanding; lead without authority; risk management; strategic planning; commercial manufacturing and CMC development; exceptional communication/stakeholder engagement.
Required Skills:
- Biologics, bioprocessing, CMC biologics, commercialization, leadership, mammalian cell culture, manufacturing scale-up, mentorship, regulatory compliance/processes, situational leadership.
- As a Biologics Cell Culture Commercialization Leader, provide strategic and tactical technical direction through cross-functional partnerships with key business units and customers.
- Support DS commercialization: process characterization, control strategy development, tech transfer to internal/external manufacturing sites, process validation, second-generation process development, and health authority licensure.
Key Responsibilities:
- Technical Strategy: deliver robust DS strategies; provide technical oversight of cell culture process development, process characterization, and regulatory filing activities to support PPQs and BLAs.
- Technical Leadership: mammalian cell culture processing expertise; independently plan, execute, analyze, and document commercialization stages; lead risk assessment, control strategies, process comparability reports, PPQ, and regulatory submissions.
- CMC Regulatory Affairs: support/writing regulatory filings (IND, MAA, BLA) and inspections with agencies (FDA, EMA, JNDA, TGA).
- Leadership: establish/manage cell culture CMC teams; align resources; mentor scientists.
- Cross-Functional Collaboration: lead in internal/external matrix teams; champion compliance and safety.
- Problem Solving: remove roadblocks, resolve conflicts, escalate as needed.
- Communication & Project Management: ensure transparency; drive schedules, priorities, and performance metrics.
- Innovation: lead business improvement initiatives.
Education & Experience:
- BS (Chem/Bioengineering or related) + 8 years industry experience OR MS + 6 years OR PhD + 3 years.
Required Experience:
- Proven leadership in biologics development/commercialization; deep expertise in cell culture commercialization and manufacturing operations; strong regulatory understanding; lead without authority; risk management; strategic planning; commercial manufacturing and CMC development; exceptional communication/stakeholder engagement.
Required Skills:
- Biologics, bioprocessing, CMC biologics, commercialization, leadership, mammalian cell culture, manufacturing scale-up, mentorship, regulatory compliance/processes, situational leadership.