Senior Scientist, Drug Product Development & CMC

Neurocrine Continental

San Diego (CA)

On-site

USD 190,000 - 270,000

Full time

3 days ago
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Job summary

Neurocrine Biosciences seeks a senior technical leader in Pharmaceutical Development to guide CMC programs from early discovery through commercialization and lifecycle management.

You will provide strategic direction on process development, material characterization, and analytical strategies to enable phase-appropriate development and regulatory success, while managing CRO/CMO/CDMO partnerships and manufacturing readiness.

Qualifications

  • Bachelor-level/advanced degree with pharmaceutical industry exposure.
  • Experience leading drug product development programs.
  • Strong knowledge of cGMP requirements and compliance.
  • Proven ability to design, scale, and transfer processes.
  • Experience with regulatory submissions and lifecycle management.

Responsibilities

  • Provide scientific and technical leadership across drug product development programs from discovery to commercial launch.
  • Lead and communicate program progress, risks, and timelines across teams.
  • Design, develop, and scale robust formulations and manufacturing processes using QbD and DoE principles.
  • Lead process development activities including DoE, process modeling, scale-up, validation, and tech transfer.
  • Act as SME to resolve complex issues across preformulation, formulation, analytical, and manufacturing activities.

Skills

DoE & statistics
QbD formulation development
CMC project leadership
Cross-functional collaboration
Regulatory submissions (IND/IMPD/NDA)

Education

BS/BA in Chemistry, Biochemistry, Chemical Engineering or related field
MS/MA in Chemistry, Biochemistry, Chemical Engineering or related field
PhD in Chemistry, Biochemistry, Chemical Engineering or related field

Job description

Neurocrine Biosciences seeks a senior technical leader in Pharmaceutical Development to guide CMC programs from early discovery through commercialization and lifecycle management.

You will provide strategic direction on process development, material characterization, and analytical strategies to enable phase-appropriate development and regulatory success, while managing CRO/CMO/CDMO partnerships and manufacturing readiness.

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