Manufacturing Lab Manager

Principal Responsibilities:

• Oversee day-to-day laboratory activities, ensuring adherence to SOPs, safety protocols, and regulatory requirements.
• Conduct STAH Explant Analysis as required.
• Support Engineering with studies in a reliability laboratory.
• Perform required development and production operational tests to ensure optimal performance of finished product.
• Develop and implement operational strategies to optimize workflow, resource utilization, and cost efficiency.
• Manage all laboratory budgets, procurement, and inventory control for chemicals, equipment, and consumables.
• Serve as the subject-matter expert in polymer synthesis, reaction control, and material performance.
• Troubleshoot complex chemical and manufacturing issues, including reaction kinetics and process deviations.
• Guide scale-up activities, ensuring reproducibility and stability of production processes.
• Recruit, train, and mentor laboratory staff, fostering a culture of accountability and collaboration.
• Maintain strict compliance with GMP, GLP, GDP, and FDA Quality System Regulations.
• Oversee hazardous material handling, storage, and disposal per RCRA and DOT regulations.
• Drive continuous improvement initiatives for laboratory processes, equipment utilization, and data integrity.
• Collaborate with Quality Assurance to resolve nonconformities and implement corrective actions.

Requirements:

• Excellent verbal communication skills with the ability to collaborate across teams.
• Strong writing skills with the ability to prepare clear, concise documentation. Highly organized with strong attention to detail.
• Ability to manage multiple tasks and priorities in a fast-paced environment.
• Proven team player with a proactive, solution-oriented mindset.
• Ability to read and interpret technical specifications, engineering drawings, and blueprints.
• Ability to maintain accurate, audit ready records and documentation.
• Proficiency using common inspection tools, including calibrated micrometers, depth gauges, rulers, and microscopes.
• Basic statistical knowledge, including calculation of averages, standard deviations, and interpretation of results.

Qualifications:

• Bachelor’s or Master’s degree in Organic Chemistry, Polymer Science, Materials Science, or related field preferred
• 7–10 years of progressively responsible experience in regulated laboratory or manufacturing environments may be considered in lieu of formal education.
• Proven leadership experience managing laboratory teams and operations.
• Strong knowledge of compliance standards, equipment validation, and clean-room practices.
• Excellent organizational, communication, and technical writing skills.

Work Environment:

The role is office-based, with laboratory environment with exposure to chemicals, limited exposure to biohazard, moving mechanical parts, and moderate noise levels. Must be able to lift up to 50 pounds. Must adhere to strict safety and protective clothing requirements.