Manufacturing Team Lead

ABOUT LGC CLINICAL DIAGNOSTICS: LGC Clinical Diagnostics develops and manufactures a comprehensive portfolio of catalogue and custom-developed diagnostic quality solutions and component materials for the extended life sciences industry. We partner with IVD assay developers, pharmaceutical, CRO and academic institutions in commercialization activities across the entire diagnostic pipeline. Laboratorians and diagnostic professionals across disciplines of clinical chemistry, immunochemistry, serology, molecular diagnostics, and clinical genomics rely on LGC’s products to support accurate and reliable diagnostic results. Our operating entities include Maine Standards Company, SeraCare Life Sciences, and Technopath Clinical Diagnostics, which are in vitro diagnostics (IVD) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT, biological materials), the Native Antigen Company, which is a manufacturer and supplier of viral antigens and LGC Proficiency Testing a global leader in PT schemes. We operate FDA-registered and ISO 13485-accredited facilities in Maine (USA), Massachusetts (USA), Maryland (USA), Tipperary (Ireland), ISO 9001-accredited facility in Oxford, UK, and Traverse City, Michigan US. Each day, our world-class staff, scientific expertise, operational efficiency, and superior quality systems are ready to support the range of advanced technologies that collectively improve patient outcomes - from the widely adopted and established through to cutting-edge NGS and precision diagnostics. As a Manufacturing Team Lead you will play a crucial role in the production of medical devices. You are to lead a manufacturing team to ensure the efficient and timely manufacturing of high-quality products that meet regulatory standards. Manufacturing Team Lead will provide direct labor for the manufacturing of high-quality diagnostic products using manual and semi-automated equipment, which includes preparing/completing required documentation on manufacturing procedures. This position is responsible for maintaining the manufacturing schedule, interpretation of in-process data, and making important decisions for manufacturing processes. This position utilizes good judgment and critical thinking skills to make high level team / production decisions regarding the quality of the products manufactured. This position is responsible for the development and aiding of goal setting of junior manufacturing associates / direct reports, and schedule adherence. To perform this job successfully, an individual must be able to capably perform each of the following essential functions: Responsibilities - Perform manufacturing tasks according to standard operating procedures (SOP) / process operating procedures (POP) and work instructions following current Good Manufacturing Practice (cGMP) and ISO 13485 quality systems. - Subject matter expert for all applicable manufacturing equipment and machinery. - Lead continuous improvement initiatives to enhance productivity and efficiency in manufacturing operations. - Lead and train junior manufacturing associates in proper procedures, techniques, and safety protocols. - Collaborate with cross-functional teams, including Project Management, Engineering, Quality Assurance, and Supply Chain, to aid / perform projects (NPD), validation activities, resolve issues, and implement process enhancements. - Own / perform investigation and resolution of non-conformances, out of specifications, and deviations, implementing corrective and preventive actions as needed. - Draft high level manufacturing instructions for manufacturing daily work as needed; review manufacturing instructions for correctness and completeness to ensure daily work is completed by manufacturing associates appropriately. - Perform required batch record reviews for completeness and good documentation practices. - Supervise, if applicable, the effective working of manufacturing personnel and prepare production schedules, taking into consideration equipment and/or resource constraints, and ensuring a commitment to both quality and company policies. - Review and analyze chemistry and serological test data after each manufacturing stage; Consult with supervisor to determine what further processing, if any, is required based on test data. - Maintain records of key performance indicators (KPIs) and provide regular progress reports to the manager. - Balance quality, productivity, cost, safety, and morale to achieve positive results in all areas of manufacturing, striving for continuous improvement. - Aid in direct reports competencies and goals. - Support additional departments as assigned to cross train and aid the business unit. - Additional functions, not specifically outlined in this position description as directed by the supervisor or manager. Minimum Qualifications: - High School Diploma; or General Educational Development (GED) - Technical certification in a related field - 4+ years in a Life Science, cGMP/ISO environment, including clean rooms in a manufacturing department role - Strong technical aptitude and problem-solving skills, with the ability to troubleshoot complex manufacturing issues - Proficient with Microsoft Office Suite, including Word, Excell, PowerPoint, and Outlook Preferred Qualifications: - Bachelor’s degree with a concentration in Biology, Chemistry, or related science - 5-6/+ years in a Life Science, cGMP/ISO environment, including clean rooms in a manufacturing department role - Manufacturing management / leadership role - SAP / Oracle ERP system experience - Experience with 5S and Lean implementation - Label printing software experience Join LGC and become part of a team that values collaboration, integrity, and brilliance in all we do. We are committed to encouraging a workplace where everyone can thrive and contribute to our mission. Our values: - PASSION - CURIOSITY - INTEGRITY - BRILLIANCE - RESPECT Equal opportunities LGC strongly believes that every job applicant and employee should be valued for their individual talents regardless of age, disability, race, color, ethnic or national origin, sex, sexual orientation, gender reassignment, marital or civil partnership, parental responsibilities, religion, or belief. Shortlisting, interviewing, and selection will always be carried out without regard to gender, sexual orientation, marital status, color, race, nationality, ethnic or national origins, religion or belief, age, or trade union membership. This position requires current U.S. work authorization. We are unable to sponsor or assume sponsorship for temporary visas (including H‑1B, H‑2B, OPT, O‑1, TN) For more information about LGC, please visit our website www.lgcgroup.com #scienceforasaferworld