Manager, Parenteral Manufacturing, Clinical Supply Operations

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Our Clinical Supply Operations is responsible for the supply of drug product administered to patients in clinical studies worldwide. In Global Product Development and Supply the team works closely with our partners to deliver quality products safely, efficiently and on time while operationalizing the innovative technologies that will deliver the transformative medicines of tomorrow. As a member of our team, you will get the chance to play a pivotal role to positively impact patients’ lives while developing professionally to achieve your own career goals.

Job Summary:

The Manager, Parenteral Manufacturing is responsible for aseptic operations and GMP production floor supervisory responsibilities. These responsibilities will include, but are not limited to, general oversight and maintenance of readiness of the facility and equipment for use in production, change management and process improvement efforts on the production floor, and supervisory responsibilities during batch execution. The individual will strive for ‘right the first time’ quality of operations and maintain a high level of GMP awareness and compliance.

Role & Responsibilities:

• Support manufacturing activities in a supervisory capacity for execution and during documentation review and approval process.  Maintain oversight of the GMP production facility for cleanliness, condition, and removal of expired materials.  Track and assure all pre-requisites for batch manufacturing are released and available as needed.
• Assist in the manufacture of pharmaceutical parenteral drug products for use in clinical studies.  Operations are carried out in a cGMP compliant manner in a controlled cleanroom environment with strict adherence to OSHA safety requirements, standard operating procedures (SOP’s) and production batch records.
• Follow all relevant procedures, batch records and protocols as required.  Ensure procedural and regulatory compliance of yourself and all operations personnel on the production floor.
• Review and revise procedures, protocols and batch records as needed to simplify and gain operational efficiency while maintaining a regulatory compliant process.
• Perform all required deviations, corrective actions and change controls within specified time limits.
• Participate in continuous improvement efforts targeted to simplify and streamline operations and/or add process capability.  Identify opportunities for continuous improvement within the department, initiate projects to implement continuous improvement changes.
• Build strong relationships and collaborate effectively with peers within the functional area and across broader organizations.  Drive delivery of functional area, project, and broader organizational-owned commitments.
• Ensure all relevant training is completed on time.  Supports training and qualification of CSO-PAR production staff.
• Maintain aseptic process training and knowledge according to local procedures, policies and trainings.  Maintain a deep understanding of cGMP’s as they relate to evolving domestic and international regulatory standards coupled with an awareness of new industry developments and trends.
• Establish and maintain a safe work environment for self and co-workers.  Ensure all safety requirements are being maintained within the production facility.  Support safety area reviews and investigations of safety events that occur.
• Support all ongoing manufacturing equipment qualification/re-qualification activities.
• Identify and escalate technical and/or business issues promptly and provide potential solutions for consideration.
• Establish effective plans for projects and assign workloads to meet de