Position Summary: The Formulations Lab Supervisor is a hands-on leadership position responsible for the direct supervision of all laboratory personnel while actively participating in the day-to-day formulation. This position serves as a working leader within the laboratory, balancing supervisory responsibilities with direct involvement in laboratory operations. The successful candidate will be expected to lead from the lab floor, perform formulations and laboratory activities alongside the team, troubleshoot issues in real time, and provide technical guidance while maintaining overall responsibility for laboratory performance, safety, quality and personnel development. Perform and oversee daily formulation and laboratory activities. Maintain adequate inventory of chemicals, reagents, and supplies. Support scale-up and transfer of formulations from laboratory quantities to manufacturing-scale production. Collect, document, review and interpret laboratory, and process data.
Supervisory Responsibilities
Supervise all lab activities, including the proper completion of all buffers, conjugations, test lines and control lines used in Chembio Diagnostic products. Assure that all lab staff can demonstrate a basic knowledge of Immunochemistry, and assure in-process review of batch records/witness formulation of product, in compliance with Departmental, Company and Government procedures and regulations. Monitor employee performance and administer company policies. Establish proper training and coaching of all lab staff. Responsible for coordinating a schedule with the Production department. Correct anomalies related to quality and efficiency within the department. Review all batch records and log books for completion and accuracy in a timely manner. Responsible for updating all batch records. Responsible for closing work orders and labor tickets in NetSuite in a timely manner. Maintain an accurate record of forward traceability for all inventory items. Assist QC in acceptance testing of incoming raw materials. Assist R&D in RIR investigations. Involvement with continuous improvement as it relates to the laboratory responsibilities. Insures compliance with regulatory standards, and adherence to all OSHA compliance laws and the requirements of the USDA and FDA. Insures departmental compliance with the requirements of cGMP. Represent the Formulations department at company meetings.
Quality & Compliance
Perform all laboratory activities in accordance with applicable GMP requirements, SOPs, safety procedures, and company quality standards. Ensure laboratory documentation is compliant with good documentation practices. Review laboratory notebooks, worksheets, formulation records, batch documentation, calculations, and other technical records. Support deviation, investigation, CAPA, change control, and non-conformance activities as required. Ensure proper identification, handling, storage, and disposal of raw materials, chemicals, samples, and laboratory waste. Maintain laboratory equipment in a clean, safe, and operational condition. Support internal, customer, and regulatory audits and inspections. Promote a culture of data integrity, quality, safety, and regulatory compliance.
Requirements
Bachelors degree in a life science or related field. 35+ years of experience in formulation supervision, batch manufacturing, or production operations, preferably within a regulated manufacturing environment. Must have a strong understanding of GMPs, SOPs, batch documentation, quality requirements, and manufacturing processes. Experience leading production teams, troubleshooting process issues, coordinating daily manufacturing activities, and driving continuous improvement is highly preferred. Experience with Microsoft Office applications, NetSuite is a plus. Management and Quality Systems coursework or training.