Manufacturing Team Lead

About the role

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

Additional Information

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.