Senior Shift Leader
- Manatí, Puerto Rico
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Leads Sterile Operations Area per shift (Par Lyo, PSA, PVA-1, PVA-2, Pharmacy and Lyo Control Functions), (Preparation, Formulation, TFF (if applicable), Filling, Lyophilization, Capping, and Sanitization). Provides guidance to all manufacturing area processes on a shift-by-shift basis in order to meet production requirements. Provides leadership and direction to the implementation of strategic projects of sterile growth products and/or any other strategic initiatives. This position must comply with all Security guidelines, Environmental Health and Safety regulations, regulatory/compliance requirements, and the current Good Manufacturing Practices required by the job function.
1. Leads the production scheduling to assure manufacturing Process Shift Leaders and Supervisors coordinate with the area planners and quality personnel, to organize and comply with daily production goals.
2. Ensures PLA, PSA, PVA-1, PVA-2, Pharmacy and Lyo Control Functions personnel complies with the established GMP's curriculum to achieve proper knowledge transfer and personnel qualification such as but not limited to aseptic techniques, Isolation technology, TFF, lyophilization, sanitization, etc.
3. Ensures that area equipment is well maintained, including but not limited to calibrations and preventive maintenances, in order to achieve optimal operational performance while maintaining regulatory and compliance requirements.
4. Participates actively in the preparation of the department budget and effectively manages company funds and actives.
5. Partners with MS&T, Eng and PMO to achieve sterile strategic growth product projects milestones.
6. Assures a streamlined and continuous operation between Sterile Operations and Non Sterile Operations.
7. Active participation on Tier 3 meetings to provide updates related to Par Lyo, PVA-1, PVA-2 and PSA activities.
8. Supports Productivity initiative programs by identifying efficiencies in the Operational areas and providing resources to support Productivity teams.
9. Supports all technology transfer activities, equipment qualification, process validation, troubleshooting clinical lots production, and process optimization by providing the necessary resources and process expertise.
10. Provides support to the regulatory affair reports, customer complaints, and area exception reports (e.g., Quality Investigation Reports, Quality Complimentary Reports, Change Request Forms, etc.).
11. Monitors, evaluates and communicates area performance metrics for processes, cost and quality control.
12. Participates actively as a key stakeholder of Parenteral Lyophilization, PVA-1, PVA-2 and PSA operations in internal and external audits.
13. Drive continuous process improvement in order to optimize product efficiency/yields.
14. Supports the creation and revision of SOP's, WFP's special test protocols and related documents to assure compliance with cGMP's, Company policies / procedures and documentation practices.
15. Maintains control of all environmental issues within PLA, PVA-1, PVA-2, Pharmacy and PSA areas.
16. Performs as back up in the absence of the Site Director, Sterile Drug Product Operations.
This is intended to be a general job description and should not be construed as all inclusive.
• BS Degree in Chemistry, Biology, Engineering, Pharmacy or related sciences.
• Ten (10) years of experience in aseptic processes, isolation technology, including lyophilization, within a pharmaceutical environment and five (5) of them in a managerial position.
• In-depth technical knowledge of the aseptic filling process, sterilization, isolation technology and lyophilization process
• Knowledge in oral solid dosage processes.
• Extensive knowledge and understanding of manufacturing processes associated with parenteral products in conventional aseptic and lyophilization technology.
• Proven strong leadership skills while maintaining effective communication and interactions with superiors and colleagues.
• Team oriented with excellent interpersonal skills.
• Strong business sense; understanding of and capability to support both financial and total quality objectives.
• Assertiveness and uncompromising attitude with regard to the quality standards applied in the day-to day activities.
• Ability to leverage both internal and external resources from various levels.
• Proficient in regulatory / compliance areas of cGMPs, FDA regulations, EHS.
• Strong interpersonal and teamwork skills; ability to develop and maintain effective professional relations with colleagues at all levels across the organization; ability to integrate actions toward objectives.
• Excellent and effective communication skills in both English and Spanish.
• Experience in writing technical reports and T&E's, executive summary type presentations to senior management and technically detailed presentations to specialized technical groups such as Technical Services, Supply Chain, Engineering and QC/QA.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
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