_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 patients with 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_ (formerly Twitter), _Facebook_ and _YouTube_. (_*in collaboration with AbbVie_)
_About the Role:_
Leads an analytical GMP group for testing development stage pharmaceutical compounds including early stage stability samples, good laboratory practice (GLP) materials, reference standards and materials, and method validation, qualification or transfer, and support for the development and manufacturing of drug substances and drug products as needed. Reviews or approves testing protocols, reports, and data from internal labs and contract service organizations (CSOs) as applicable. Reviews or approves specification revisions, certificates of testing (CoT) for GLP materials and certificates of analysis (CoAs) for reference standards. Responsible for analytical instrument and equipment qualification. Oversees analytical GMP group to ensure timely deliverables. Conducts work in compliance with safety and regulatory requirements.
_Your Contributions (include, but are not limited to):_
- Oversee internal GMP laboratory operations, including staffing, scheduling, budgeting, and resource allocation to meet team objectives and goals
- Implements strategic plans and translates into team's objectives for evaluation criteria for obtaining results; contributes to department strategy determination
- Develop, implement, and maintain SOPs, systems, and daily practices to uphold GMP compliance within the internal laboratory
- Manage internal stability testing programs, validation, qualification, and transfer of analytical test methods, instrument qualification, and characterization of GLP/GMP samples
- Lead the qualification, calibration, and maintenance programs for laboratory instruments to ensure compliance and data integrity
- Supervise and review the work and data generated by in-sourced personnel, ensuring accuracy, completeness, and adherence to quality standards
- Manages in-source personnel work and review of the data as needed
- Maintain complete and accurate documentation of all laboratory activities, including test results, equipment qualification records, SOPs, and training records
- Hire, train, and develop laboratory personnel to support efficient, compliant, and high-quality operations
- Prepare for and participate in internal and external audits and regulatory inspections, ensuring continuous readiness and compliance
- Identify and resolve laboratory operational issues and implement process improvements to enhance efficiency and quality
- Develops and evaluates personnel to ensure the efficient operation of the function
_Requirements:_
- Bachelor's degree in Chemistry or other life science and 12+ years of analytical experience in the pharmaceutical industry or relevant industry experience. Including managing pharmaceutical analytical method testing, qualification, stability and troubleshooting. Experience in assessment of technical data to provide technical reviews of analytical data, documents, and regulatory submissions OR
- Master's degree in Chemistry or other life science and 10+ years pharmaceutical industry experience OR
- PhD in Chemistry or other life science and 7+ years of related experiences. Some management or leader experience is preferred
- Expert in at least one analytical scientific discipline
- Strong knowledge of analytical method validation and transfer
- Working knowledge of ICH and FDA guidance for analytical method validation, stability, CTD, and submission of analytical data
- Strong knowledge in the assessment of technical data in order to provide technical reviews of analytical data, documents, and regulatory submissions
- Self-motivated, well-organized, with ability to work independently and enjoy scientific investigation and thinking, proactively identifying issues and developing solutions in a collaborative multidisciplinary environment
- Working knowledge of cGMP, GLP and GDP
- Requires understanding of how the team / work area relates to other related areas and uses that knowledge to improve efficiency and produce high-quality work on problems with cross-functional impact
- Identifies and resolves technical, operational and organizational problems/problems relating to own discipline
- Frequently works cross-functionally as the representative for their area
- Ability to develop alternative solutions to difficult problems
- Ability to work as part of and lead multiple teams
- Good leadership skills and abilities and able to manage teams.
- Excellent computer skills
- Excellent communications, problem-solving, analytical thinking skills
- Ability to meet deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
- Strong project management skills
- Attention to detail and confidentiality are essential
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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.
