1. Oversees equipment readiness, ensuring timely calibrations, preventive maintenance, and adherence to regulatory and safety standards. 4. Operational Integration Facilitates seamless coordination between Manufacturing and Inspection operations to support uninterrupted product flow and minimize bottlenecks. 5. Identifies and implements improvements to enhance product yield, operational efficiency, and regulatory compliance. 13. 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. 14. Environmental Control Maintains environmental compliance and control within PVA, PVLA, or PSA areas, ensuring a safe and sterile manufacturing environment. 15. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Supporting People with Disabilities 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. 2. Production Scheduling & Coordination Aligns manufacturing supervisors, area planners, and Quality personnel to coordinate daily production schedules and meet output goals efficiently. 3. Leads the Manufacturing Alignment Team, driving strategic initiatives and ensuring consistency across PVA, PVLA, or PSA operations. 6. Budget & Resource Management Contributes to departmental budget planning and manages resources effectively to optimize cost control and operational efficiency. 7. Productivity & Continuous Improvement Champions productivity initiatives by identifying process efficiencies and allocating resources to support cross-functional improvement efforts. 8. Technical Support & Process Optimization Provides expert guidance and resources for technology transfer, equipment qualification, process validation, clinical lot troubleshooting, and ongoing process optimization. 9. Regulatory & Quality Support Supports regulatory submissions, customer complaint investigations, and exception reports (e.g., QIRs, QCRs, CRFs), ensuring timely and accurate documentation. 10. Performance Monitoring & Data-Driven Decisions Monitors and communicates key performance indicators (KPIs) related to process efficiency, cost, and quality to drive informed decision-making. 11. Audit Readiness & Representation Serves as a primary contact for internal and external audits, representing PVA, PVLA, or PSA operations and ensuring audit preparedness. 12. Models and promotes BMS Core Behaviors, fostering a culture of teamwork, accountability, coaching, and continuous feedback. 16. Site-Wide Engagement Actively supports site-wide initiatives and fulfills additional responsibilities as assigned to meet evolving business needs. 17. Serves as the designated backup for the Associate Director of Drug Product Operations during absences, ensuring continuity of leadership and decision-making. 18. Digital Communication & Escalation Maintains continuous digital communication of area status and escalates issues promptly to ensure timely resolution and alignment with operational priorities. 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 diverse 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.