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 **.
Qualifications & Experience**
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.
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.
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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 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 then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. 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. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Supporting People with Disabilities
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection **.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company:** Bristol-Myers Squibb
Req Number: R1597423
Updated: 2025-12-07 04:59:13.493 UTC
Location: Manati-PR
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
