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Position: Manager, Parenteral Manufacturing Isolation Technology- Night Shift

Location: Manati - PR

1. Oversees resources availability (material, equipment, personnel –regular and lease workers) necessary to meet and comply with timely preparations, formulation and filling production plan.

2. Verifies adherence to procedures and Isolation Technology controls and provides corrective feedback during operations by frequent monitoring of production activities

3. Performs systematic walkthroughs of operation floors.

4. Ensures areas housekeeping and compliance with control areas facilities requirements.

5. Establishes corrective actions plan to eliminate process deviations and documentation errors.

6. Supports efforts to release lots on hold and conducts thorough reviews of investigation reports.

7. Supports Annual Requalification Program by assuring on time execution of requalification activities

8. Supports Environmental Monitoring and media fill Programs by assuring compliance with the corresponding procedure requirements.

9. Defines job skill requirement for the manufacturing positions which includes back up operators for critical positions in the Isolation Technology environment and supports the training program design assuring adherence to training plan including employee certification and re-certification program.

10. Prepares and/or approves necessary SOP’s and forms to be in full compliance with cGMP’s and reflect manufacturing processes.

11.Supports Maintenance and Calibration Program by assuring on time execution of applicable preventive and corrective maintenance plans.

12. Provides process support to Technology Transfer activities in order to align it with the manufacturing needs.

13. Supports the site Quality Systems and Compliance efforts.

14. Review and approve new or existing products Regulatory Filings.

15. Complies with Company Environmental, Health, and Safety goals programs and objectives.

16. Monitors scrap factor, equipment downtime, and labor utilization on a regular basis for effective and efficient production plan execution.

17. Identifies opportunities to improve process performance and / or safety requirements.

18. Leads Continuous Improvement initiatives in the manufacturing area.

19. Generates and approve changes as per the established Change Control procedure.

20. Assists in preparing manufacturing budget, and establishes effective cost control programs to meet budget targets and objectives per company strategic plan.

21. Prepares on time performance reviews and manage disciplinary actions as needed.

22. Monitors attendance trends enforcing applicable Company policies and procedures.

23. Assesses and prepares development training in target areas in order to increase manufacturing technician’s proficiency in current technology and assignments e.g. FMEA Risk Assessment documents, RCA (root cause analysis), etc.

24. Prepares work schedules and match employees with the required skill set for the jobs to be accomplished.

25. Coordinates daily Parenteral Lyophilization manufacturing activities and resources allocation including manufacturing areas sanitization (controlled and non-controlled areas), components preparation and lyophilization activities.

26. Provides continuity to the operations as required.

27. Verifies all the manufacturing documentation and ensure it is completed and in compliance.

28. Provides coaching and feedback to employees which includes employee disciplinary investigations and execution of disciplinary actions when necessary as per Company Policies.

29. Facilitates the coordination of any manufacturing related activities with support areas (eg. Maintenance, QA/QC, TS, SC,etc.) to ensure flawless execution on processes, equipment evaluations, product transfer and other activities.

30. Assists the Area Manager and the support groups to solve any production technical problem (eg. Process /equipment troubleshooting, QE’s, CAPA’s, yield, cycle time, quality and productivity).

31. Performs administrative functions such as personnel performance appraisals and development action plans, vacation schedules and approval, attendance (Kronos) administration for payroll processing, personnel leave of absences administration, budget activities and projections etc.

32. Performs as back up of the area Manager as required.

• Bachelor Degree in Science, Administration, or Engineering.
• Five (5) years of experience in Compounding, Sterilization, Aseptic Filling and/or Lyophilization processes, and product transfer validation in a Pharmaceutical manufacturing environment.
• Three (3) years of solid supervisory experience, or leading multidisciplinary teams (disciplinary actions, performance appraisals, development of succession plans, etc).
• In depth knowledge in Aseptic Processing •Strong Project Management skills.
• Ability to lead continuous innovation initiatives, foster team building and simplify processes.
• Ability to prepare and understand technical documents such as FMEA’s, Risk Assessments, Cause and Effect diagrams, Designs of Experiment (DOE) etc
• Ability to maintain good employee relations and to handle grievances and complaints.
• Self-starter with strong leadership characteristics, analytical, administrative and people skills
• Ability to communicate and work effectively in a team oriented environment.
• Knowledge of cGMPs, safety and environmental regulations, human resources and labor laws.
• Personal computer skills, knowledge in Excel, Word, PowerPoint, Internet.
• Fully bilingual oral and written (Spanish/English). Technical writing skills.
• Sense of urgency and business needs.
• Capability to use protective gowning.
• Willing to work irregular hours, rotation shifts, weekends and holidays, when necessary.

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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.

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 an inclusive culture, promoting diversity 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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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