Supervisor, Quality Control Analytical Chemistry Laboratory

Afton Scientific is a contract manufacturing organization (CMO) in Virginia that specializes in small-batch filling of injectables from clinical trials to approved commercial drugs.

Utilizing 35,000 Sq. Ft of manufacturing, lab, warehouse, and administrative space, Afton provides custom, innovative solutions for clinical to commercial sterile manufacturing, packaging and labeling, analytical and micro lab services, and pharmaceutical support services.

Our Ready-To-Fill® line continues with our philosophy of guidance and support for our clients. It offers top-quality pre-sterilized components to those who can fill in-house.

• Serving clients in 18 Countries
• Successful NDA and ANDA drug registrations
• In good standing with the FDA, PMDA, and MHRA

NOTE: Afton Scientific does not sponsor work visas. No recruiters please.

Supervisor, Quality Control Analytical Chemistry Laboratory

Department: Quality Control

Reports To: Manager, QC Analytical Lab

FLSA Status: Exempt

Location: On-Site – Charlottesville, VA

Afton Scientific is seeking an experienced and collaborative Supervisor, Quality Control Analytical Chemistry Laboratory to provide day-to-day leadership for our Analytical Chemistry Laboratory. This position is responsible for supervising laboratory operations, supporting and developing laboratory personnel, ensuring compliance with cGMP and regulatory requirements, and providing technical leadership in support of pharmaceutical manufacturing and quality operations.

This opportunity is ideal for an individual who combines strong analytical chemistry expertise with proven leadership, sound decision-making, and a commitment to quality and continuous improvement.

Compensation

$90,000 - $110,000 annually, depending on experience and qualifications.

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

Primary Responsibilities

·         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.

Minimum Qualifications

·         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.

Preferred Knowledge and Experience

·         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 Competencies

·         Leadership & Accountability

·         Coaching & Employee Development

·         Communication & Collaboration

·         Planning & Prioritization

·         Technical Expertise

·         Quality & Regulatory Compliance

·         Continuous Improvement

·         Sound Judgment & Decision Making