Manufacturing Team Lead
About The Position
The Manufacturing Team Lead leads a manufacturing team to ensure efficient, timely production of high-quality diagnostic products that meet regulatory standards. The role also performs direct manufacturing labor using manual and semi-automated equipment and completes required manufacturing documentation. It is responsible for maintaining the manufacturing schedule, interpreting in-process data, making manufacturing-process decisions, and applying judgment and critical thinking to decisions about product quality. The role supports junior associates’ development and goal setting and ensures schedule adherence.
Requirements
- High school diploma or GED.
- Technical certification in a related field.
- At least 4 years of experience in a Life Science, cGMP/ISO environment, including clean rooms in a manufacturing department role.
- Strong technical aptitude and problem-solving skills, including the ability to troubleshoot complex manufacturing issues.
- Proficiency with Microsoft Office Suite, including Word, Excel, PowerPoint, and Outlook.
- Current U.S. work authorization; the company is unable to sponsor or assume sponsorship for temporary visas.
Nice To Haves
- Bachelor’s degree with a concentration in Biology, Chemistry, or a related science.
- 5–6 or more years of experience in a Life Science, cGMP/ISO environment, including clean rooms in a manufacturing department role.
- Experience in a manufacturing management or leadership role.
- Experience with SAP or Oracle ERP systems.
- Experience with 5S and Lean implementation.
- Experience with label printing software.
Responsibilities
- Perform manufacturing tasks according to SOPs, POPs, and work instructions, following cGMP and ISO 13485 quality systems.
- Serve as a subject matter expert for applicable manufacturing equipment and machinery.
- Lead continuous improvement initiatives to improve manufacturing productivity and efficiency.
- Lead and train junior manufacturing associates in procedures, techniques, and safety protocols.
- Collaborate with Project Management, Engineering, Quality Assurance, and Supply Chain on projects, new product development, validation activities, issue resolution, and process enhancements.
- Own or perform investigations and resolutions of non-conformances, out-of-specifications, and deviations, and implement corrective and preventive actions as needed.
- Draft high-level manufacturing instructions as needed and review instructions for correctness and completeness.
- Review batch records for completeness and good documentation practices.
- Where applicable, supervise manufacturing personnel and prepare production schedules while accounting for equipment and resource constraints and ensuring compliance with quality and company policies.
- Review and analyze chemistry and serological test data after each manufacturing stage and consult with the supervisor about any further processing required.
- Maintain key performance indicator records and provide regular progress reports to the manager.
- Balance quality, productivity, cost, safety, and morale while pursuing continuous improvement.
- Support direct reports’ competencies and goals.
- Cross-train and support additional departments as assigned.
- Perform other functions as directed by a supervisor or manager.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
