Manager, Parenteral Manufacturing - Isolation Technology

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. 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.

PRINCIPAL OBJECTIVE OF POSITION     

Provides strategic leadership and operational oversight for the Parenteral Vial (PVA), Parenteral Syringes (PSA), or Parenteral Vial Liquid Area (PVLA) manufacturing areas—including Preparation, Formulation, Filling, Lyophilization, Capping, and Sanitization—to ensure the consistent production of high-quality sterile pharmaceutical products. The Manager serves as a key supervisory figure, guiding teams and processes to meet production targets, quality standards, and compliance expectations. This role requires adherence to all applicable Environmental Health and Safety (EHS) regulations, Security protocols, regulatory requirements, and current Good Manufacturing Practices (cGMP). The position also fosters a culture of continuous improvement, operational excellence, and team development.

MAJOR DUTIES AND RESPONSIBILITIES   

• Personnel Qualification & Training
  Ensures all personnel are trained and qualified according to the established curriculum, including aseptic techniques, isolation procedures, lyophilization, and sanitization, to maintain operational readiness and regulatory compliance.

• Production Scheduling & Coordination
  Aligns manufacturing supervisors, area planners, and Quality personnel to coordinate daily production schedules and meet output goals efficiently.

• Equipment Reliability & Compliance
  Oversees equipment readiness, ensuring timely calibrations, preventive maintenance, and adherence to regulatory and safety standards.

• Operational Integration
  Facilitates seamless coordination between Manufacturing and Inspection operations to support uninterrupted product flow and minimize bottlenecks.

• Team Leadership & Strategic Alignment
  Leads the Manufacturing Alignment Team, driving strategic initiatives and ensuring consistency across PVA, PVLA, or PSA operations.

• Budget & Resource Management
  Contributes to departmental budget planning and manages resources effectively to optimize cost control and operational efficiency.

• Productivity & Continuous Improvement
  Champions productivity initiatives by identifying process efficiencies and allocating resources to support cross-functional improvement efforts.

• Technical Support & Process Optimization
  Provides expert guidance and resources for technology transfer, equipment qualification, process validation, clinical lot troubleshooting, and ongoing process optimization.

• Regulatory & Quality Support
  Supports regulatory submissions, customer complaint investigations, and exception reports (e.g., QIRs, QCRs, CRFs), ensuring timely and accurate documentation.

• Performance Monitoring & Data-Driven Decisions
  Monitors and communicates key performance indicators (KPIs) related to process efficiency, cost, and quality to drive informed decision-making.

• Audit Readiness & Representation
  Serves as a primary contact for internal and external audits, representing PVA, PVLA, or PSA operations and ensuring audit preparedness.

• Process Improvement & Compliance
  Identifies and implements improvements to enhance product yield, operational efficiency, and regulatory compliance.

• Deviation & Documentation Management
  Oversees the creation and revision of SOPs, WFPs, special test protocols, and related documentation to ensure alignment with cGMP, company policies, and documentation standards. Develops and implements corrective action plans to address process deviations and