Sr. Manager, Analytical Development GMP Lab
Neurocrine Biosciences
Senior Manager leading analytical development and GMP laboratory operations at a biopharmaceutical company. Oversees team, laboratory operations, method validation, and regulatory compliance across preclinical through commercial programs.
Responsibilities
- Oversee laboratory operations including staffing, scheduling, budgeting, and resource allocation
- Develop and implement SOPs, systems, and practices ensuring GMP compliance and data integrity
- Lead analytical method development, validation, qualification, and technology transfer activities
- Manage instrument qualification, calibration, and maintenance compliance programs
- Hire, train, and develop laboratory personnel while supervising work quality and regulatory adherence
Requirements
- Bachelor's in Chemistry or life science with 8+ years pharmaceutical analytical experience
- Master's degree with 6+ years applicable experience or PhD with 4+ years
- Working knowledge of cGMP, GLP, and GDP regulations
- Expert proficiency in at least one analytical scientific discipline
- Strong expertise in analytical method validation and technology transfer
- Working knowledge of ICH and FDA guidance for validation, stability, and submissions
Vacancy posted 6 days ago
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