Sr. Manager, Analytical Development GMP Lab

About the role

Leads an analytical GMP group for testing development stage pharmaceutical compounds including early stage stability samples, good laboratory practice (GLP) materials, reference standards and materials, and method validation, qualification or transfer, and support for the development and manufacturing of drug substances and drug products as needed.

Reviews or approves testing protocols, reports, and data from internal labs and contract service organizations (CSOs) as applicable.

Reviews or approves specification revisions, certificates of testing (CoT) for GLP materials and certificates of analysis (CoAs) for reference standards.

Responsible for analytical instrument and equipment qualification.

Oversees analytical GMP group to ensure timely deliverables.

Conducts work in compliance with safety and regulatory requirements.

Responsibilities

• Oversee internal GMP 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
• 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

Requirements

• Bachelor's degree in Chemistry or other life science and 12+ years of analytical experience in the pharmaceutical industry or relevant industry experience. 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 OR
• Master's degree in Chemistry or other life science and 10+ years pharmaceutical industry experience OR
• PhD in Chemistry or other life science and 7+ years of related experiences. Some management or leader experience is preferred
• 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
• 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
• Working knowledge of cGMP, GLP and GDP
• 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
• Identifies and resolves technical, operational and organizational problems/problems relating to own discipline
• Frequently works cross-functionally as the representative for their area
• Able to develop alternative solutions to difficult problems
• Able 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
• Able 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

Benefits

• 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.