What are the responsibilities and job description for the ASEPTIC MANUFACTURING SUPERVISOR (3RD SHIFT) position at PeopleSuite LLC?
Scope of Position
The Fill / Finish Supervisor oversees GMP manufacturing processes, focusing on the aseptic production of finished biologic drug products for Phase I / II and commercial GMP manufacturing. This hands-on role involves leading a team of technicians, ensuring compliance with industry regulations, and maintaining operational efficiency and product quality. This is a third-shift position.
Responsibilities
- Supervise and lead a team of manufacturing technicians, providing guidance and support.
- Ensure all projects comply with cGMP regulations, safety standards, and established protocols.
- Oversee the production of clinical and commercial materials, meeting strategic objectives and quality benchmarks.
- Conduct on-the-job training to enhance staff skills and maintain aseptic qualifications.
- Assign tasks and coordinate emergency responses during shifts.
- Ensure accurate documentation of processes, including batch records and standard operating procedures (SOPs).
- Collaborate with cross-functional teams, including Quality Assurance (QA) and Manufacturing, to optimize processes and resolve issues.
- Support scale-up and trial-run projects by providing hands-on assistance during manufacturing.
- Monitor product stability and conduct shelf-life testing.
- Prepare and review material purchase orders and equipment load lists.
- Document field conditions, project updates, and deviations from standard processes.
- Conduct safety inspections, report incidents, and implement corrective actions.
- Provide performance reviews, set annual goals, and conduct one-on-one mentoring sessions.
- Identify and implement continuous improvement initiatives.
- Perform other duties as assigned.
Qualifications
Physical Demands
Preferred Skills
LI-DNI
