Senior Scientist, CMC Downstream Process Development

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:

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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 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. OR

• 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 OR

• 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

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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.

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