Sr. Manager, Analytical Development GMP Lab

Neurocrine Biosciences • San Diego, CA

7d • $143,600 - $196,000

About The Position

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.

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

Responsibilities

• 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 function
• Leads 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

Benefits

• retirement savings plan (with company match)
• paid vacation
• holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Manager