Supervisor, Quality Control Analytical Chemistry Laboratory

Placement within the range will be based on qualifications, experience, internal equity, and demonstrated competencies.

·         Bachelor's degree in Chemistry or a related scientific discipline.

·         Minimum of five to seven years of pharmaceutical analytical laboratory experience.

·         Demonstrated expertise with analytical instrumentation, including HPLC, FTIR, GC, Karl Fischer Titration (KFT), UV-Vis, and comparable technologies.

·         Working knowledge of cGMP, GDP, and GLP principles within a pharmaceutical environment.

·         Strong written and verbal communication skills.

·         Proficiency with Microsoft Office applications and the ability to learn additional laboratory software systems.

·         Ability to work on-site full-time and perform the physical requirements of a laboratory environment.

·         Supervise daily operations of the Quality Control Analytical Chemistry Laboratory while supporting production and quality objectives.

·         Assist in managing, coaching, and developing laboratory staff in partnership with the QC Analytical Chemistry Laboratory Manager.

·         Perform and oversee analytical testing of pharmaceutical finished products, APIs, and raw materials in accordance with applicable pharmacopeial and regulatory requirements.

·         Ensure laboratory operations comply with FDA, ICH, USP, NF, EU, JP, cGMP, GDP, and GLP requirements.

·         Design, execute, document, and support validation of laboratory methods, instrumentation, equipment, and analytical techniques.

·         Assist in developing, qualifying, and implementing analytical test methods.

·         Analyze, interpret, and document laboratory results in accordance with approved procedures.

·         Review laboratory documentation and executed testing for accuracy, completeness, and regulatory compliance.

·         Coordinate preventative maintenance, calibration, and verification activities for laboratory instrumentation.

·         Investigate technical issues, identify root causes, and implement effective solutions.

·         Write, review, edit, and approve controlled documents, including SOPs, validation protocols, specifications, reports, investigations, and quality system documentation.

·         Participate in client, internal, and regulatory audits while representing the laboratory in a professional manner.

·         Support procurement of laboratory equipment and supplies while maintaining effective relationships with clients, vendors, and internal stakeholders.

·         Previous supervisory or team leadership experience in a pharmaceutical quality control laboratory.

·         Experience reviewing SOPs, deviations, excursions, investigations, and quality documentation.

·         Experience with biologics testing techniques such as ELISA, SDS-PAGE, CE-SDS, or icIEF.

·         Experience supporting regulatory inspections and client audits.

·         Strong problem-solving, organizational, and decision-making skills.

·         Demonstrated commitment to quality, continuous improvement, and employee development.

·         Leadership & Accountability

·         Coaching & Employee Development

·         Communication & Collaboration

·         Planning & Prioritization

·         Technical Expertise

·         Quality & Regulatory Compliance

·         Continuous Improvement

·         Sound Judgment & Decision Making