Senior Scientist, CMC Downstream Process Development
Neurocrine Biosciences
September 02, 2026
Remote friendly (San Diego, CA)
United States
Operations
About The Role:
Serve as the scientific leader for assigned assets, shaping development strategy through deep process understanding and ensuring regulatory defensibility. Guide asset progression from early development through commercialization, defining technical direction, leading critical risk assessments, and ensuring scientific rigor supports lifecycle strategy and manufacturing readiness.
Your Contributions (include, but are not limited to):
- Apply advanced scientific or engineering principles to complex process development challenges
- Serve as the primary scientific decision-maker for assigned assets
- Lead process scale-up and technology transfer initiatives; proactively manage technical risk
- Plan and manage scientific activities and represent development in cross-functional teams
- Maintain accountability for asset-level deliverables and production planning
- Lead technical risk assessments to support project advancement
- Independently design and oversee advanced activities supporting clinical through commercial development
- Supervise laboratory and pilot-scale work and ensure safe laboratory practices
- Identify and resolve significant process challenges using data-driven approaches
- Recommend solutions to improve product quality and manufacturing consistency
- Manage contract manufacturing activities and contractor relationships
- Provide scientific leadership in CMC regulatory documentation
- Contribute to departmental scientific policies and standards
- Mentor scientists; build internal/external professional relationships
- Perform other duties as assigned
Requirements:
- BS/BA (chemistry/biochemistry/biology or similar) OR chemical/biochemical engineering (or similar) AND 12+ years in pharmaceutical/process development (including API manufacturing in-plant activities); lab management experience desired
OR
- MS/MA AND 10+ years relevant experience
OR
- PhD AND 4+ years relevant experience (may include postdoc)
Skills/Qualifications (required):
- Broad, deep subject matter expertise; recognized authority defending scientific strategy
- Creative, effective solutions; understands interdependencies
- Leads multiple teams/initiatives; strong leadership and mentoring
- Excellent communication and analytical skills; strong project management
- Thorough understanding of process development and scale-up
- Knowledge of validation and control strategy development
- Manufacturing experience (internal/external)
- Strong understanding of cGMP and regulatory requirements
- Demonstrated cross-functional drug development knowledge
- Advanced laboratory equipment/tool proficiency
Compensation & Benefits:
- Annual base salary: $130,800.00–$179,000.00; annual bonus target 30% of earned base salary; eligibility for equity long-term incentive program
- Retirement plan match; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical/prescription drug/dental/vision coverage
Serve as the scientific leader for assigned assets, shaping development strategy through deep process understanding and ensuring regulatory defensibility. Guide asset progression from early development through commercialization, defining technical direction, leading critical risk assessments, and ensuring scientific rigor supports lifecycle strategy and manufacturing readiness.
Your Contributions (include, but are not limited to):
- Apply advanced scientific or engineering principles to complex process development challenges
- Serve as the primary scientific decision-maker for assigned assets
- Lead process scale-up and technology transfer initiatives; proactively manage technical risk
- Plan and manage scientific activities and represent development in cross-functional teams
- Maintain accountability for asset-level deliverables and production planning
- Lead technical risk assessments to support project advancement
- Independently design and oversee advanced activities supporting clinical through commercial development
- Supervise laboratory and pilot-scale work and ensure safe laboratory practices
- Identify and resolve significant process challenges using data-driven approaches
- Recommend solutions to improve product quality and manufacturing consistency
- Manage contract manufacturing activities and contractor relationships
- Provide scientific leadership in CMC regulatory documentation
- Contribute to departmental scientific policies and standards
- Mentor scientists; build internal/external professional relationships
- Perform other duties as assigned
Requirements:
- BS/BA (chemistry/biochemistry/biology or similar) OR chemical/biochemical engineering (or similar) AND 12+ years in pharmaceutical/process development (including API manufacturing in-plant activities); lab management experience desired
OR
- MS/MA AND 10+ years relevant experience
OR
- PhD AND 4+ years relevant experience (may include postdoc)
Skills/Qualifications (required):
- Broad, deep subject matter expertise; recognized authority defending scientific strategy
- Creative, effective solutions; understands interdependencies
- Leads multiple teams/initiatives; strong leadership and mentoring
- Excellent communication and analytical skills; strong project management
- Thorough understanding of process development and scale-up
- Knowledge of validation and control strategy development
- Manufacturing experience (internal/external)
- Strong understanding of cGMP and regulatory requirements
- Demonstrated cross-functional drug development knowledge
- Advanced laboratory equipment/tool proficiency
Compensation & Benefits:
- Annual base salary: $130,800.00–$179,000.00; annual bonus target 30% of earned base salary; eligibility for equity long-term incentive program
- Retirement plan match; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical/prescription drug/dental/vision coverage