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 are not limited to):

• Establish relationships and actively manage external parties (CROs, CDMOs, Raw material suppliers, consultants, etc) to support biologics programs - Responsible for all process development-related activities and CMOs results, including Technology Transfer to CMO partner sites for manufacturing of different phases of clinical studies, registration stability lots, and validation batches

• Manage priorities and timelines while also creating value by devising new possibilities for IP, incorporating QbD principles when possible, and practicing the best/most practical technologies

• Prepare and review regulatory filings (including INDs, IMPDs, NDAs, briefing packages, or other regulatory dossiers)

• Manage assessment capabilities within the Product Development Department, including sourcing & procuring instruments and equipment required to perform process and analytical studies

• Provide instrument/equipment and method training for other personnel to promote broad utilization of analytics capabilities within the PD department and CMC

• Proactively researches drug product manufacturing processes based on current regulatory and ICH guidelines for modern pharmaceutical development

• A strong technical background encompassing protein chemistry is required

• Assimilates data and research findings outside of Neurocrine for application to new scientific projects

• Maintains broad knowledge of scientific principles and theories and possesses intellectual mastery of one or more scientific areas

• May develop an understanding of other areas and related dependencies

• Advanced knowledge and demonstrated ability working with / recommending a variety of laboratory equipment/tools

• Ability to work as part of and lead multiple teams

• Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams

• Excellent computer skills, communication, problem-solving, and analytical thinking skills. sees the broader picture, and 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

• Excellent project management skills

• Candidate must exhibit the technical ability to execute and troubleshoot experiments through rational and critical thinking.

• Must be highly organized and detail-oriented

• Hands-on experience with analytical techniques used for protein characterization and stability testing is required

• Prior CMC development experience in protein formulation, lyophilization process development, drug delivery, or analytical functions is highly preferred

• Search, assess, and share/teach up-to-date scientific and technical knowledge and information of various biologics formulation/process approaches related to the company's drug product development programs

• Manage performance assessment testing capabilities (analytics) within the biologics group

• Provide instrument and method training for other personnel to promote the utilization of the biologics process and testing capabilities

• Work independently on assignments using knowledge and work experience; support other activities of drug product development programs when needed

Requirements:

• BA/BS degree in Chemistry, Biochemistry, Biology, Chemical Engineering, or related field and 8+ years (Sr. scientist) /12+ years (principal scientist) of pharmaceutical industry experience OR

• Master's degree in Pharmaceutics, Chemistry, Biochemistry, Biology, Chemical Engineering, or related field preferred and 6+ years (Sr. scientist) /10+ years (principal scientist) of similar experience noted above OR

• Ph. D. (preferred) in Pharmaceutics, Analytical Chemistry, Chemistry and 1+ years (Sr. scientist) /6+ years (principal scientist) similar experience noted above

• Thorough understanding of principles and design of various formulations (preferred experience in both peptides/proteins and antibodies)

• Extensive hands-on experience and knowledge of various formulations e.g., HPLC testing, etc.

• Good understanding of health authority regulations and guidelines for drug product development and approval processes

• Knowledge in statistics and statistical thinking in formulation and process design and validation

• Good knowledge of various drug product manufacturing processes

• Good understanding of drug development and commercialization processes

• Excellent capability in strategic thinking and planning

• Working knowledge in the following instrument/testing: HPLC, LCMS, DSC, Particle-Size Analysis, etc.

• Working knowledge in applying QbD principles in drug product development

• Technical writing: protocols, reports, SOPs, etc.

• Other duties as assigned.

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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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