Senior Scientist, CMC Downstream Process Development

Neurocrine Biosciences; San Diego (CA); On-site; USD 131,000 - 179,000; Full time

Job summary

Neurocrine Biosciences seeks a scientific leader for assigned development assets, shaping strategy from early development through commercialization and ensuring regulatory defensibility. You will guide technical direction, lead risk assessments, and mentor scientists while coordinating cross-functional teams across QA, manufacturing, and regulatory.

This role emphasizes process development, scale-up, tech transfer, and making data-driven decisions to improve product quality and manufacturing

Qualifications

• Advanced degree in chemistry or engineering, with substantial pharma process development experience.
• Experience leading multiple teams and cross-functional drug development.
• Strong communication and analytical skills.
• Knowledge of cGMP and regulatory requirements.
• Experience with scale-up and technology transfer.

Responsibilities

• Apply advanced principles to solve complex process development challenges.
• Lead process scale-up and technology transfer initiatives.
• Plan and manage scientific activities in cross-functional teams.
• Mentor scientists and manage asset-level deliverables.
• Provide scientific leadership for regulatory documentation.
• Manage contract manufacturing activities.
• Identify and resolve process challenges using data-driven approaches.
• Maintain safety and productivity in lab operations.

Skills

Scientific leadership

Cross-functional collaboration

Risk assessment

Data-driven decision making

Project management

Education

PhD in chemistry or related

MS in chemistry or related

BS in chemistry or related

Tools

Laboratory instrumentation

Process validation tools

Job description

Who We Are

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company’s diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington’s disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)

About the Role

Serve as the scientific leader for assigned assets, shaping development strategy through deep process understanding and ensuring regulatory defensibility of key decisions. Combines advanced technical expertise with cross-functional influence, guiding asset progression from early development through commercialization. As the primary scientific authority for your programs, define technical direction, lead critical risk assessments, and ensure that scientific rigor guides lifecycle strategy and manufacturing readiness.

Your Contributions

• 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 managing technical risk
• Plan and manage scientific activities; 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 innovative solutions to improve product quality and manufacturing consistency
• Manage contract manufacturing activities and contractor relationships
• Provide scientific leadership in CMC regulatory documentation
• Contribute to development of departmental scientific policies and standards
• Mentor scientists and support professional development
• Build and strengthen internal and external professional relationships
• Perform other duties as assigned

Requirements

• BS/BA in chemistry, biochemistry, biology, or similar scientific discipline OR chemical engineering, biochemical engineering, or similar engineering discipline AND 12+ years of experience in experience in pharmaceutical/process development field, including API manufacturing person in plant activities, Experience managing laboratory, maximizing productivity is desirable.
• MS/MA in chemistry, biochemistry, biology, or similar scientific discipline OR chemical engineering, biochemical engineering, or similar engineering discipline AND 10+ years of similar experience noted above.
• PhD in chemistry, biochemistry, biology or similar scientific discipline OR chemical engineering, biochemical engineering, or similar engineering AND 4+ years of relevant experience; may include postdoc experience.
• Broad and deep knowledge of scientific or engineering principles with subject matter expertise.
• Recognized authority capable of defending scientific strategy.
• Develops creative and effective solutions to technical challenges.
• Understands interdependencies across functional areas.
• Leads multiple teams or initiatives.
• Demonstrates strong leadership and mentoring skills.
• Excellent communication and analytical skills.
• Understands impact across multiple programs and departments.
• Manages multiple priorities with high accuracy.
• Strong project management skills.
• Thorough understanding of process development and scale-up strategies.
• Excellent laboratory and productivity skills.
• Knowledge of validation and control strategy development.
• Manufacturing experience internally and externally.
• Strong understanding of cGMP and regulatory requirements.
• Demonstrated cross-functional drug development knowledge.
• Advanced proficiency with laboratory equipment and tools #LI-LS1

EEO & Diversity

Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.

Salary & Benefits

The annual base salary we reasonably expect to pay is $130,800.00-$179,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program.

• Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

We are a top place to work. Neurocrine Biosciences was named one of the FORTUNE Best Workplaces in Biopharma 2025. We were also named a Great Place to Work Certified company.

Our Values

• PASSION: We are driven and love what we do.
• INTEGRITY: We do the right thing for patients and our community. We take accountability. We speak up.
• COLLABORATION: We trust one another. We are inclusive. We are respectful. We are transparent. Together we succeed.
• INNOVATION: We seek and create optimal solutions.
• TENACITY: We do not quit. We adapt. We accomplish what others cannot.

Join Us

Come join our team during this exciting time of growth and opportunities!