Supervisor, Manufacturing - Swing Shift; Mon - Fri *PC

Your Role

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,

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.

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.

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.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel;

reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

This job is performed…