Manager, Parenteral Manufacturing Isolation Technology

Job description

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. Manager, Parenteral Manufacturing - Isolation Technology (Night Shift) 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 documentation errors, ensuring regulatory compliance and operational integrity. Environmental Control Maintains environmental compliance and control within PVA, PVLA, or PSA areas, ensuring a safe and sterile manufacturing environment. Leadership & Culture Building Models and promotes BMS Core Behaviors, fostering a culture of teamwork, accountability, coaching, and continuous feedback. Site-Wide Engagement Actively supports site-wide initiatives and fulfills additional responsibilities as assigned to meet evolving business needs. Leadership Continuity Serves as the designated backup for the Associate Director of Drug Product Operations during absences, ensuring continuity of leadership and decision-making. Digital Communication & Escalation Maintains continuous digital communication of area status and escalates issues promptly to ensure timely resolution and alignment with operational priorities. KNOWLEDGE / SKILL Education: Bachelor’s degree (BS) in Chemistry, Biology, Engineering, Pharmacy, or a related scientific discipline is required. Advanced degrees (e.g., MS, MBA) are considered a plus. Experience: Minimum of 10 years of progressive experience in aseptic pharmaceutical manufacturing, including lyophilization or sterile filling operations. At least 5 years in a managerial or leading role, demonstrating effective leadership in a regulated environment. Experience with Isolation Technology is highly desirable. Technical Expertise: Deep understanding of parenteral product manufacturing processes, including aseptic techniques. Proficient in regulatory compliance, including cGMPs, FDA regulations, and Environmental Health and Safety (EHS) standards. Skilled in interpreting and applying quality systems, documentation practices, and validation protocols. Leadership & Interpersonal Skills: Proven ability to lead cross-functional teams, drive performance, and foster a culture of accountability and continuous improvement. Strong interpersonal skills with the ability to build effective relationships across all organizational levels. Demonstrated capability to coach, mentor, and develop team members Business Acumen: Solid understanding of financial principles and operational cost drivers. Ability to align manufacturing objectives with broader business goals, including productivity, quality, and compliance. Communication: Excellent verbal and written communication skills in both English and Spanish, with the ability to tailor messaging for technical teams, senior leadership, and regulatory audiences. Experience in preparing and delivering executive summaries, technical reports, and presentations to stakeholders including Technical Services, Supply Chain, Engineering, and Quality Assurance/Control. Ability to maintain continuous digital communication of area status and escalate issues promptly to ensure timely resolution and alignment with operational priorities. Professional Attributes: Assertive and uncompromising in upholding quality standards and regulatory expectations. Resourceful in leveraging internal and external networks to resolve challenges and drive innovation. Highly organized, detail-oriented, and capable of managing multiple priorities in a dynamic environment If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Manati - PR - US: $77,700 - $94,152 The starting compensation range(s) for this role are listed above for a full-time em