Principal Scientist, Pharmaceutical Development
Neurocrine Biosciences
August 24, 2026
On-site
San Diego, CA
Operations
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 and oversee CRO/CMO/CDMO partnerships; represent CMC on cross-functional teams to deliver high-quality drug products.
Your Contributions
- Provide scientific/technical leadership across drug product development programs from early discovery through commercial launch.
- Lead internal and external project team meetings; communicate progress, risks, resource gaps, and timelines.
- Design, develop, and scale robust, phase-appropriate formulations and manufacturing processes using QbD and statistical methods.
- Lead process development (DoE, modeling, scale-up, validation, and technology transfer).
- Act as SME to resolve complex technical issues (preformulation, formulation, analytical, manufacturing); drive root-cause analysis.
- Oversee external partners (CDMOs/vendors) to ensure technical capability, quality, compliance, and material supply.
- Serve as technical lead during manufacturing campaigns/on-site (“person-in-plant”).
- Collaborate cross-functionally and lead/support CMC strategy, including regulatory submission sections (IND/IMPD/NDA/MAA) and documentation (ICH/FDA/EMA/cGMP).
- Drive CPV/CPI via monitoring CPPs/CQAs; provide mentorship; perform other duties as assigned.
Requirements
- BS/BA (Chemistry/Biochem/ChemE or related) + 6+ years in pharma (chemistry/analytical/characterization lab).
- OR MS/MA + 4+ years.
- OR PhD + 2+ years (postdoc allowed).
- Parenteral drug product development experience (mAbs/peptides/conjugates); combination product design preferred.
- Strong cGMP knowledge; deep parenteral process design/optimization/scale-up/validation/lifecycle.
- Expertise managing CROs and CMOs/CDMOs; analytical method validation/technology transfer/stability.
- Regulatory experience authoring/reviewing drug product sections of INDs/NDAs.
Benefits (as stated)
- Annual base salary: $130,800–$179,000; annual bonus target 30% and equity long-term incentive eligibility; retirement match; paid vacation/holidays/personal days; caregiver/parental and medical leave; medical/prescription/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 and oversee CRO/CMO/CDMO partnerships; represent CMC on cross-functional teams to deliver high-quality drug products.
Your Contributions
- Provide scientific/technical leadership across drug product development programs from early discovery through commercial launch.
- Lead internal and external project team meetings; communicate progress, risks, resource gaps, and timelines.
- Design, develop, and scale robust, phase-appropriate formulations and manufacturing processes using QbD and statistical methods.
- Lead process development (DoE, modeling, scale-up, validation, and technology transfer).
- Act as SME to resolve complex technical issues (preformulation, formulation, analytical, manufacturing); drive root-cause analysis.
- Oversee external partners (CDMOs/vendors) to ensure technical capability, quality, compliance, and material supply.
- Serve as technical lead during manufacturing campaigns/on-site (“person-in-plant”).
- Collaborate cross-functionally and lead/support CMC strategy, including regulatory submission sections (IND/IMPD/NDA/MAA) and documentation (ICH/FDA/EMA/cGMP).
- Drive CPV/CPI via monitoring CPPs/CQAs; provide mentorship; perform other duties as assigned.
Requirements
- BS/BA (Chemistry/Biochem/ChemE or related) + 6+ years in pharma (chemistry/analytical/characterization lab).
- OR MS/MA + 4+ years.
- OR PhD + 2+ years (postdoc allowed).
- Parenteral drug product development experience (mAbs/peptides/conjugates); combination product design preferred.
- Strong cGMP knowledge; deep parenteral process design/optimization/scale-up/validation/lifecycle.
- Expertise managing CROs and CMOs/CDMOs; analytical method validation/technology transfer/stability.
- Regulatory experience authoring/reviewing drug product sections of INDs/NDAs.
Benefits (as stated)
- Annual base salary: $130,800–$179,000; annual bonus target 30% and equity long-term incentive eligibility; retirement match; paid vacation/holidays/personal days; caregiver/parental and medical leave; medical/prescription/dental/vision.