Manager of Manufacturing
About this job
Responsible for oversight, coordination, and supervision of personnel and manufacturing activities for preparation of cell products for clinical trials and eventual commercial sale. The incumbent will work with the VP of Manufacturing and contract parties to establish acceptable processes for two or more cell therapy products and engage in technology transfer of these processes to contract facilities. The incumbent will then be responsible for oversight of a contractor operating a cGMP manufacturing facility for the production of cell therapy products. Specialized knowledge and expertise are used in performing technical aspects of the job, exercising judgment within generally defined practices and policies.
Oversee the scheduling of process development and daily cGMP manufacturing activities to ensure the availability of staff, raw materials, and processing equipment. Serve as the point person to coordinate with manufacturing supervisors, project sponsors, and management to resolve scheduling conflicts that may arise.
Perform regular manufacturing capacity planning and forecasting by coordinating with the different project sponsors to ensure product is manufactured and delivered on timely basis to meet clinical needs. Work with clinical staff to ensure manufacturing readiness and coordinated scheduling of leukaphereses at clinical sites.
Schedule, train and supervise personnel, including cross training to provide backup capabilities. Coordinate with leadership in other departments to ensure that all areas are staffed appropriately as project workload and priorities shift.
Oversee and as required perform technical procedures related to the preparation of cell products. Coordinate with Bellicum Research and Development staff to integrate and qualify/validate analytical methods developed for in-process and release testing of cell therapy products.
Supervise daily contract manufacturing activities to ensure the accuracy, completeness and timeliness of record keeping including: schedules, log books, batch records, records of user activity, supply inventories, equipment use and maintenance and monthly billing. Maintain cGMP documentation/notebooks to be compliant with federal regulations and for federal audits.
Partner with QA to ensure cGMP compliance through the continuous improvement of quality systems and ensuring that processes, raw materials, and processing equipment are qualified and validated for their intended use.
Will participate in the strategic planning processes as requested. Perform other responsibilities as required.
Skills, Education, and Experience Required
MS/BS in life sciences or engineering with 10+ years of experience in the field.
Expertise in cell culture based manufacturing processes for primary cells is preferred.
A minimum of five years related experience in cGMP operations and working in controlled therapeutic manufacturing environments is highly preferred.
Additional requirements include strong supervisory and leadership skills, project management skills and communication skills. Ability to work both independently and as part of a team demonstrating excellent communication and interpersonal skills is required. Knowledge of cGMP and FDA device/drug/biologics regulations.
Experience with process and equipment qualification and validation.
Bellicum offers a competitive compensation and benefits package.