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

Compensation Overview:

Manati - PR - US: $77,700 - $94,152

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

Work-life benefits include:

Paid Time Off

• US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays

Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.