Bayer Associate Director, GMP Operations in Morristown, NJ, New Jersey
Your tasks and responsibilities
•The Associate Director GMP Operations is responsible for the operations and day to day activities for the GMP Pilot Plant area. He/she will lead the team that is responsible for the maintenance and upkeep of the Morristown GMP facility. •In addition, they lead the technicians that will support manufacture of batches for consumer and/or clinical supplies manufactured at the Morristown facility. This includes training and development of personnel, maintenance of the facility, ensuring compliance of facility, and leading production operations at a pilot scale. •The Associate Directory GMP Facility the equipment and instruments within the GMP area are calibrated and maintained as required to meet cGMPs. This position will also manage a calibration budget of $200k and capital budget of $1.5MM.
The incumbent will: • Enable the successful performance of direct reports by: - Evaluating performance and providing performance-related feedback; - Ensuring his/her team delivers upon commitments; - Helping direct reports improve skills in areas where most in need; - Facilitating training opportunities when applicable;
• Ensure the ongoing compliance of the Pilot Plant by: - Maintaining area procedures and ensuring adherence; - Coordinating ongoing facility testing and monitoring; - Ensuring the quality and accuracy of documentation generated in the area; - Maintaining the qualified state of the GMP area; - Maintaining/updating a cleaning validation master plan; - Maintaining/updating a site master validation plan;
• Ensure efficient area operations by: - Maintaining adequate material and supplies inventory; - Leading process for scheduling equipment and personnel to support batch execution for both; Therapeutics and Personal Care Units; - Long term resource planning to ensure readiness to support projects;
• Ensure the proper and effective equipment are used by: - Ensuring the GMP equipment is capable of supporting the NPD pipeline; - Ensuring that GMP equipment is representative of equipment used at manufacturing sites; - Ensure that the equipment is safe and in good working order;
Who you are
• Bachelor’s degree (or international equivalent) with a minimum of 10 years of relevant experience, Master’s degree (or international equivalent) with a minimum of 6 years of relevant experience, or Ph.D with postdoctoral work with and a minimum of 4 years of relevant experience; • Significant experience with global GMP requirements for facilities and equipment; • Experience managing team and people; • Working knowledge of standard GMP unit operations; • Significant experience with the compliance requirements for the manufacturing of registration and clinical batches.
Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.