Sr. Principal Engineer, Tech Transfer
Neurocrine Biosciences
August 30, 2026
Remote friendly (San Diego, CA)
United States
Operations
About The Role
Leads the design and execution of formulation and process development activities across the product lifecycle, supporting programs from early development through commercialization and delivering phase-appropriate drug products aligned with target product profiles.
Responsibilities
- Set and drive enterprise-level strategy for drug product formulation and manufacturing across the portfolio.
- Provide authoritative technical leadership within CMC, guiding program direction from early development through commercialization and lifecycle management.
- Define and govern development strategies for formulations and manufacturing processes using QbD, DoE, modeling, and statistical approaches.
- Oversee process development, scale-up, validation, and global technology transfer to enable reliable clinical and commercial supply.
- Lead CMC subteams; coordinate cross-functional teams and communicate risks, timelines, and resources.
- Provide SME oversight for complex investigations, risk assessments, and issue resolution.
- Direct CDMO/vendor strategy and performance management to ensure technical excellence and compliance.
- Own CMC regulatory strategy and deliverables (IND, IMPD, NDA, MAA) for successful global submissions.
- Establish lifecycle management strategies (CPV, CPI) and proactive risk management for CPPs/quality attributes.
- Champion innovation in enabling technologies and advanced manufacturing approaches.
- Lead knowledge management/standard-setting; mentor scientific staff.
Requirements
- BA/BS in Chemical Engineering, Pharmaceutical Sciences, or related Life Sciences + 10+ years pharmaceutical industry experience (chemistry/analytical/characterization), OR
- Master’s + 8+ years, OR
- PhD + 6+ years (may include postdoc).
Leads the design and execution of formulation and process development activities across the product lifecycle, supporting programs from early development through commercialization and delivering phase-appropriate drug products aligned with target product profiles.
Responsibilities
- Set and drive enterprise-level strategy for drug product formulation and manufacturing across the portfolio.
- Provide authoritative technical leadership within CMC, guiding program direction from early development through commercialization and lifecycle management.
- Define and govern development strategies for formulations and manufacturing processes using QbD, DoE, modeling, and statistical approaches.
- Oversee process development, scale-up, validation, and global technology transfer to enable reliable clinical and commercial supply.
- Lead CMC subteams; coordinate cross-functional teams and communicate risks, timelines, and resources.
- Provide SME oversight for complex investigations, risk assessments, and issue resolution.
- Direct CDMO/vendor strategy and performance management to ensure technical excellence and compliance.
- Own CMC regulatory strategy and deliverables (IND, IMPD, NDA, MAA) for successful global submissions.
- Establish lifecycle management strategies (CPV, CPI) and proactive risk management for CPPs/quality attributes.
- Champion innovation in enabling technologies and advanced manufacturing approaches.
- Lead knowledge management/standard-setting; mentor scientific staff.
Requirements
- BA/BS in Chemical Engineering, Pharmaceutical Sciences, or related Life Sciences + 10+ years pharmaceutical industry experience (chemistry/analytical/characterization), OR
- Master’s + 8+ years, OR
- PhD + 6+ years (may include postdoc).