Sr. Manager, Analytical Development GMP Lab

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 )

At Neurocrine, strong leadership drives both business results and team success. We look for leaders who think strategically, anticipate what’s ahead and set clear direction, while building and empowering high-performing teams. Successful leaders foster an environment where people are motivated to do their best work and deliver meaningful, measurable impact through sound decision-making and accountability.



About the Role:

Leads analytical development and GMP laboratory operations supporting programs from preclinical development through commercialization, ensuring high-quality, compliant analytical execution and delivery. Provides strategic, technical, and people leadership while collaborating across functions and with external partners to advance CMC objectives. _

Your Contributions (include, but are not limited to):

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

Requirements:

• •Bachelor's degree in Chemistry or other life science and 8+ years of analytical experience in the pharmaceutical industry or relevant industry experience OR
• •Master's degree in Chemistry or other life science and 6+ years of applicable experience OR
• •PhD in Chemistry or other life science and 4+ years of applicable experience
• •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 depen