Analytical Laboratory Manager

About the role

The Analytical Laboratory Manager oversees method development, validation, and method verification activities, ensuring compliance with cGMPs, GLPs, and SOPs. This role also coordinates chemical analysis and data review for various samples.

Responsibilities

• Plan and supervise analytical development activities ensuring regulatory and industry standards are met.
• Oversee laboratory investigations, problem-solving, and troubleshooting related to analytical projects.
• Manage method development and validation activities, testing intermediates, finished products, and samples for pre-commercial release or stability.
• Review and approve method verification and validation protocols, reports, and analytical methods.
• Ensure documentation is accurate, relevant, clear, and concise, adhering to cGMPs, GLPs, and SOPs.
• Work collaboratively with QC Laboratory Management, R&D Innovation, Project Management, and other departments.
• Support QC Laboratory operations for lifecycle management of analytical methods and legacy method remediation.
• Initiate and coordinate analytical method transfer processes from AD to internal QC Labs or external partners.
• Determine and schedule AD personnel to meet testing cycle times and commitments.
• Develop, maintain, and report KPIs for AD activities.
• Create and sustain a respectful and inclusive workplace, supporting open communication.
• Address complaints and resolve problems.

Requirements

• Bachelor’s degree in chemistry, biochemistry, or related science.
• 10+ years of experience in a quality control laboratory role or equivalent combination of higher education and relevant work experience.
• 5+ years of professional leadership, supervisory, and/or management experience.
• In-depth, hands-on experience in various analytical techniques and instrumentation.
• Thorough knowledge of cGMP regulations, GLPs, laboratory management processes, and quality management systems.
• Ability to work independently, determine resources, and meet deadlines.
• Expertise in problem-solving, analytical skills, and mathematical concepts.
• Proficiency in Microsoft Office, including Word, Excel, Teams, and Outlook.
• Practical problem-solving and trouble-shooting skills.

Qualifications

• Education: Bachelor’s degree in chemistry, biochemistry, or related science.
• Experience: 10+ years of experience in a quality control laboratory role or equivalent combination of higher education and relevant work experience.
• Leadership: 5+ years of professional leadership, supervisory, and/or management experience.
• Technical Skills: In-depth, hands-on experience in various analytical techniques and instrumentation.
• Regulatory Knowledge: Thorough knowledge of cGMP regulations, GLPs, and laboratory management processes.
• Problem-Solving: Expertise in problem-solving, analytical skills, and mathematical concepts.
• Communication: Proficiency in Microsoft Office, including Word, Excel, Teams, and Outlook.
• Technical Skills: Practical problem-solving and trouble-shooting skills.

Preferred Qualifications

• General knowledge of USP monographs for product testing and techniques.
• Experience with budget estimates and CapEx investment strategy.
• Experience with Computer Systems Validation.
• Experience with SAP.
• Experience with electronic laboratory software systems.