At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs, but few options.

Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis* and uterine fibroids*, as well as clinical programs in multiple therapeutic areas. For 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. *in collaboration with AbbVie

About the Role:

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Your Contributions (include, but not limited to):

• Oversee the chemical development activities for biologics, including API development, vendor tech transfer, manufacturing and support, process validation, and troubleshooting

• Lead and manage the API biologics team within CMC in collaboration with directors and teams in CMC drug product and analytical groups, ensuring the successful execution of development programs for biologic products

• Collaborate closely with cross-functional teams, including Research and Development, Quality Assurance, Regulatory Affairs, and Clinical Development to ensure timely and successful CMC activities

• Develop and implement CMC strategies for biologics API

• Provide technical expertise and guidance on CMC-related issues, ensuring compliance with regulatory guidelines and requirements

• Actively participate in regulatory submissions, including INDs, NDAs, and BLAs, and represent the company in interactions with regulatory authorities

• BS/BA degree in Chemistry and 10+ years of experience in pharmaceutical biologics, including API development and manufacturing experience, OR

• MS/MA degree in Chemistry and 8+ years of similar experience above, OR

• PhD in Chemistry and 5+ years relevant industry experience

• Proven track record of successfully leading CMC teams and managing complex projects

• Expertise in both upstream and downstream processing and development is highly desirable

• Deep understanding of regulatory guidelines and requirements related to CMC activities

• Strong leadership and communication skills, with the ability to collaborate effectively across teams and stakeholders

• Experience managing external partners, CDMOs and manufacturers

• Excellent problem-solving abilities and a proactive approach to decision-making

• Proficient in all aspects of modern biologics development, purification, and analysis

• Sees broader picture, impact on multiple programs, teams and/or departments

• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency

#LI-DM1

Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

We are committed to building a diverse, equitable, and inclusive workplace, 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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