Principal Engineer, Solid Oral Drug Development – Scale-Up

Neurocrine Biosciences, Inc.; San Diego (CA); On-site; USD 157,000 - 214,000; Full time

Benefits offered by this job

Retirement savings plan (company match

Paid vacation

Public holidays & personal days

Parental & medical leave

Health benefits

Job summary

Neurocrine Biosciences is seeking a Principal Engineer in Pharmaceutical Development for solid oral drug products. You will provide scientific leadership across late-stage programs, guiding process development from Phase 2/3 manufacturing through scale-up and control strategy.

Collaboration with MSAT, Formulation, Analytical Development, and external CDMOs is essential. The role emphasizes regulatory submissions support (INDs/NDAs/MAAs), technology transfer, and lifecycle management.

Qualifications

• BS/BA or MS/MA or PhD with 8+/6+/4+ years in pharmaceutical process engineering.
• Strong cross-functional understanding of formulation and analytical development.

Responsibilities

• Serve as SME in process engineering for solid oral drug products across multiple programs.
• Design fit-for-purpose processes (granulation, encapsulation, tablet compression, coating).
• Lead DoE studies and risk assessments for robust manufacturing.
• Provide technical oversight of CDMO partners and review regulatory documentation.
• Mentor junior scientists/engineers and influence program strategy.

Skills

Process engineering

Cross-functional collaboration

Quality by Design (QbD)

Design of Experiments (DoE)

Regulatory readiness

Analytical thinking

Project leadership

Technical mentorship

Education

BS/BA in Chemistry, Biochemistry, Chemical Engineering

MS/MA in Chemistry, Biochemistry, Chemical Engineering

PhD in Chemistry, Biochemistry, Chemical Engineering

Tools

JMP software

Compaction Simulator (Style One)

Roller Compaction (Gerteis)

Encapsulators (Bosch)

Tablet presses (Korsch)

Fluid beds (Glatt)

Job description

Neurocrine Biosciences is seeking a Principal Engineer in Pharmaceutical Development for solid oral drug products. You will provide scientific leadership across late-stage programs, guiding process development from Phase 2/3 manufacturing through scale-up and control strategy.

Collaboration with MSAT, Formulation, Analytical Development, and external CDMOs is essential. The role emphasizes regulatory submissions support (INDs/NDAs/MAAs), technology transfer, and lifecycle management.