About the position
Kindeva Drug Delivery is seeking a motivated and passionate Supervisor/TL, Production to join our team in Bridgeton, MO. As a leading global contract developer and manufacturer (CDMO), we specialize in delivery platform expertise in Autoinjector, Inhalation, and Transdermal/Intradermal Patch Technologies. In this role, you will supervise aseptic filling and sterile sub-assembly operations, ensuring that all processes are performed in compliance with current Good Manufacturing Practices (cGMP) and following Standard Operating Procedures (SOPs). You will be responsible for instructing union operators in their daily duties, ensuring timely performance and adherence to safety requirements. Your responsibilities will include conducting GMP audits of the aseptic processing area, investigating process deviations, and performing daily reviews of area batch records for accuracy. You will also be tasked with composing or revising departmental SOPs, reporting significant shift activities to the Manager/TL, and coordinating personnel activities to ensure appropriate coverage in the department. Training new operators and conducting performance reviews will be part of your duties, along with maintaining inventory on materials and sterile items used in the aseptic processing area. Additionally, you will assist in the development and maintenance of the annual department overhead budget, order supplies, and maintain communication with various departments to coordinate batch records, equipment maintenance, and quality control testing. Aseptic Quality Coaching will be a continuous part of your role, as you observe and review aseptic practices on the manufacturing floor. You will also assist the Production Manager with special projects and other duties as assigned, ensuring a safe and compliant working environment for all team members.
Responsibilities
- Supervise aseptic filling and sterile sub-assembly operations and union operators.
- Instruct operators in daily duties and ensure compliance with cGMP and SOPs.
- Conduct GMP audits of the aseptic processing area and investigate process deviations.
- Perform daily reviews of area batch records for accuracy and compliance with SOPs.
- Compose or revise departmental SOPs as required.
- Report significant shift activities to the Manager/TL and conduct root cause analysis.
- Coordinate personnel activities to ensure appropriate coverage in the department.
- Train new operators and conduct performance reviews with operators.
- Maintain inventory on materials and sterile items used in the aseptic processing area.
- Assist in the development and maintenance of the annual department overhead budget and order supplies.
- Maintain communication with Manufacturing Resource Coordinators and other departments for coordination of activities.
- Continuously observe and review aseptic practices on the manufacturing floor.
- Assist the Production Manager with special projects and other duties as assigned.
Requirements
- Bachelor's degree in Engineering, Chemistry, Computer Science, or other Technology or Life Science field.
- Minimum of two years prior work experience in a relevant field; pharmaceutical background is helpful.
- Prior experience in a union shop setting is beneficial.
- Background in manufacturing and supervision is highly desirable.
- Effective written and oral communication skills in English.
- Computer literate with skills in managing Microsoft Applications, PLS, and Trackwise.
- Demonstrated reading comprehension and writing proficiency.
- Proven problem-solving and decision-making skills.
Nice-to-haves
- Experience in a pharmaceutical manufacturing environment.
- Knowledge of aseptic processing and quality control standards.
Benefits
- Health insurance coverage.
- 401k retirement savings plan.
- Paid time off for holidays and vacations.
- Opportunities for professional development and training.
