Supervisor, Manufacturing - Swing Shift (Mon - Fri 1pm-9:30pm) PC 568

Miltenyi Biomedicine•San Jose, CA

7d•$98,354 - $115,710•Onsite

About The Position

This position will oversee day to day production activities for Manufacturing personnel including batch record review, timecard approvals, performance reviews, training, and document or deviation reviews and approvals. The role involves overseeing and actively participating in GMP manufacturing processes, training and managing GMP staff, and ensuring department training (GMP, Safety, Corporate) is performed and documented. The supervisor will monitor the maintenance of production equipment and facilities for GMP manufacturing suites, and oversee complete documentation of all required production activities, ensuring compliance with cGMP, SOPs, corporate policies, and safety practices. They will also develop documentation to support operations, ensure adherence to schedule, coordinate manufacturing operations, and investigate failures to determine root cause and implement CAPA. The role requires ensuring timely completion and submission of investigation reports and deviation documentation, troubleshooting production issues with QA, driving Continuous Process Improvement, ensuring quality standards are met, assessing resource needs, reducing production costs, improving efficiencies, and working closely with the Leadership team to meet company goals. Additionally, the supervisor will provide leadership on projects, promote career development, and communicate performance appraisals.

Requirements

Bachelor's Degree and a minimum of 2-5 years' experience in a GMP biologicals production facility AND a minimum 1 year progressive supervisory or management experience.
Experience with clinical cell culture production, aseptic processing, and/or Cell Therapy product manufacturing necessary.
Experience in people management as a supervisor or Senior/Lead associate.
Ability to work in a swing shift environment.

Nice To Haves

Experience with Manufacturing operations in a Controlled Environment
Ability to work cross functionally with both internal and external stakeholders
Driver of Continuous Process Improvement
Familiarity with GMP regulations and Quality systems
Experience in a life science or biotech environment desired
Able to motivate and lead individuals to achieve desired goals
Effective communication skills and the ability to influence others

Responsibilities

Oversee and actively participate in GMP manufacturing processes.
Train and manage the performance of the GMP staff, ensure that department training (GMP, Safety, Corporate) is performed and documented.
Monitor the maintenance of production equipment and facilities for the GMP manufacturing suites.
Oversee complete documentation of all required production activities and ensure compliance with current Good Manufacturing Practice regulations (cGMP), Standard Operating Procedures (SOPs), corporate policies and safety practices.
Develop documentation (i.e., batch records, SOPs and documents) to support equipment/facility operations.
Ensure adherence to schedule as provided by Department head. Coordinate all manufacturing operations within the facility and regularly communicate the schedule within the manufacturing department and other groups as necessary.
Investigate all failures (equipment, process, product) and assist in determining root cause. Responsible for ensuring appropriate CAPA are identified and implemented following approved SOPs.
Ensure timely completion and submission of all Manufacturing Investigation Report and documentation of deviations to minimize production delays.
Work with QA and others to troubleshoot production issues and drive Continuous Process Improvement Initiatives.
Ensure quality standards are always met or exceeded.
Proactively assess resource needs and lead efforts to reduce production costs and improve efficiencies.
Work closely with Leadership team and other departments to meet company goals and objectives.
Provide leadership on projects and process improvement teams.
Promote Career Development and communicate clear and objective performance appraisals.