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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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.
