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San Diego, California, United States
Onsite
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)
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Oversee internal 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 functionLeads and manages analytical development and GMP laboratory activities supporting programs from preclinical development through commercialization
Represents Analytical Development on cross-functional teams and maintains accountability for analytical deliverables, timelines, and CMC plans
Develops and implements analytical strategies, methods, and novel approaches to support Chemical and Product Development activities
Oversees analytical method development, validation, qualification, transfer, stability testing, and characterization of GLP/GMP samples
Directs internal laboratory operations, including staffing, scheduling, budgeting, resource allocation, and safe laboratory practices
Establishes and maintains SOPs, systems, documentation, and laboratory practices to ensure GMP compliance, data integrity, and inspection readiness
Oversees laboratory instrument qualification, calibration, maintenance, and associated compliance programs
Provides technical oversight and reviews laboratory work and data to ensure accuracy, completeness, quality, and regulatory compliance
Supports external analytical activities, including method transfers, manufacturing support, and oversight and collaboration with contractors and external partners
Provides analytical input into CMC regulatory documentation and applies scientific literature, ICH/regulatory guidance, and technical expertise to influence CMC strategies
Develops and implements department strategies, policies, operational improvements, and team objectives to enhance quality and efficiency
Hires, leads, coaches, and develops laboratory personnel, supporting performance, technical growth, career development, and effective team operations
Working knowledge of cGMP, GLP and GDP
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
Identifies and resolves technical, operational and organizational problems/problems relating to own discipline
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
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
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
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.
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The annual base salary we reasonably expect to pay is $143,600.00-$196,000.00. 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.