Sr. Scientist, Pharmaceutical Development
Neurocrine Biosciences
September 01, 2026
On-site
San Diego, CA
Clinical Research and Development
About the Role
Serve as a senior technical leader within Pharmaceutical Development representing CMC project teams across the product lifecycle from early discovery through commercialization and lifecycle management. Provide strategic/scientific leadership in process development, material characterization, and analytical strategies; manage developability risks; and support IP and commercial objectives. Establish/oversee CRO/CMO/CDMO partnerships and provide CMC representation on cross-functional teams.
Your Contributions
- Lead drug product development programs from early discovery through launch; align goals, timelines, and regulatory expectations
- Run internal/NBI–CMO/CDMO project meetings; communicate progress, risks, resource gaps, and timelines
- Design/develop/scale robust, phase-appropriate formulations and manufacturing processes using QbD and statistical methods
- Lead process development (DoE, modeling, scale-up, validation, technology transfer)
- Serve as SME to resolve complex preformulation/formulation/analytical/manufacturing issues via root-cause analysis
- Oversee external partners (CDMOs/vendors) to ensure capability, quality, compliance, and supply
- Act as technical lead/person-in-plant during manufacturing campaigns
- Author/review regulatory submissions and development documentation (IND, IMPD, NDA, MAA; ICH/FDA/EMA/cGMP)
- Drive CPV/CPI via CPP/CQA monitoring; mentor teammates; other duties as assigned
Requirements
- BS/BA + 6+ years OR MS/MA + 4+ years OR PhD + 2+ years (Chemistry/Biochemistry/Chemical Engineering or related)
- Advanced cGMP drug product manufacturing knowledge and quality/compliance mindset
- Expertise in product development (process design/optimization/scale-up/validation/lifecycle)
- Analytical methods, method validation, technology transfer, stability programs
- Regulatory expertise authoring/reviewing drug product sections of INDs/NDAs
- Experience managing CROs and CMOs/CDMOs; IND/NDA experience
Benefits (as stated)
- Base salary: $130,800–$179,000; annual bonus target 30%; equity long-term incentive eligibility
- Retirement match, paid vacation/holidays/personal days, caregiver/parental and medical leave; health benefits (medical, prescription drug, dental, vision).
Serve as a senior technical leader within Pharmaceutical Development representing CMC project teams across the product lifecycle from early discovery through commercialization and lifecycle management. Provide strategic/scientific leadership in process development, material characterization, and analytical strategies; manage developability risks; and support IP and commercial objectives. Establish/oversee CRO/CMO/CDMO partnerships and provide CMC representation on cross-functional teams.
Your Contributions
- Lead drug product development programs from early discovery through launch; align goals, timelines, and regulatory expectations
- Run internal/NBI–CMO/CDMO project meetings; communicate progress, risks, resource gaps, and timelines
- Design/develop/scale robust, phase-appropriate formulations and manufacturing processes using QbD and statistical methods
- Lead process development (DoE, modeling, scale-up, validation, technology transfer)
- Serve as SME to resolve complex preformulation/formulation/analytical/manufacturing issues via root-cause analysis
- Oversee external partners (CDMOs/vendors) to ensure capability, quality, compliance, and supply
- Act as technical lead/person-in-plant during manufacturing campaigns
- Author/review regulatory submissions and development documentation (IND, IMPD, NDA, MAA; ICH/FDA/EMA/cGMP)
- Drive CPV/CPI via CPP/CQA monitoring; mentor teammates; other duties as assigned
Requirements
- BS/BA + 6+ years OR MS/MA + 4+ years OR PhD + 2+ years (Chemistry/Biochemistry/Chemical Engineering or related)
- Advanced cGMP drug product manufacturing knowledge and quality/compliance mindset
- Expertise in product development (process design/optimization/scale-up/validation/lifecycle)
- Analytical methods, method validation, technology transfer, stability programs
- Regulatory expertise authoring/reviewing drug product sections of INDs/NDAs
- Experience managing CROs and CMOs/CDMOs; IND/NDA experience
Benefits (as stated)
- Base salary: $130,800–$179,000; annual bonus target 30%; equity long-term incentive eligibility
- Retirement match, paid vacation/holidays/personal days, caregiver/parental and medical leave; health benefits (medical, prescription drug, dental, vision).