Associate Director - Microbiology

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.

KNOWLEDGE / SKILL :

• PhD or Masters in Microbiology, Biology or Equivalent scientific field
  
• Ten (10) years of progressive managerial experience within the quality operations function of a pharmaceutical/health care industry and regulatory agencies, with experience in microbiology laboratories and aseptic controls.
  
• Knowledge in microbiological instrumentation and techniques and aseptic processes.
  
• Strong leadership skills
  
• Proficient in cGMP's and FDA regulations and requirements.
  
• Excellent interpersonal skills
  
• Working knowledge in PC's and electronic tools.
  
• Excellent communication skills in both English and Spanish
  
• A systematic decision maker, assuring decisions are fact based and clearly documented
  
• Planning skills
  
• Excellent analytical and problem solving skills
  
• Excellent verbal, written and presentation skills and have the ability to deal effectively with all levels of management
  
• Must be innovative and creative and utilize all available resources.
  
• Knowledge in Operational Excellence and Lean Laboratory
  

MAJOR DUTIES AND RESPONSIBILITIES:
1. Develops and implements goals, objectives and mechanisms to ensure the optimum operational, science based and regulatory performance of the microbiological testing laboratory consistent with departmental and site strategies, SOPs and WWQ&C policies.
2. Oversights microbiological testing of raw materials, finished products, in-process, USP water and cleaning samples. Supports validation activities of the site ensuring microbiological testing of validation samples is performed within the required timelines.
3. Coordinates administrative activities, ex. HR issues, budget, hiring, performance partnerships, etc.
4. Provides technical leadership and guidance to the site QC Microbiology staff to ensure timely completion of goals and objectives.
5. Prioritizes projects and determines resource constraints when necessary.
6. Ensures that site Microbiology Processes staff receives training in appropriate procedures and protocols, including safety, cGMP training, etc. Overall, assures compliance with all accepted laboratory and safety procedures.
7. Ensures that the Microbiology personnel have the required materials, equipment and tools to support site operations.
8. Serve as a key liaison with the Microbiology and Compliance Network.
9. Participates on project teams and Microbiology network to ensure that laboratories representation is provided on technical issues.
10. Assures that data and reports generated are consistent and accurate and completed within the required timelines.
11. Interfaces with other BMS groups in GPS on project issues to build collaboration and harmonization within the development and manufacturing network at BMS. Ensures that all activities are performed in compliance with federal and local regulatory agencies (e.g., OSHA, EPA, FDA, etc.).
12. Maintains a safe work environment for Microbiological laboratories personnel.
13. Interacts and supports inspections and regulatory submissions concerning Microbiology matters. (ie: Environmental Monitoring, Microbial Methods validation, Aseptic Practices, etc.)
14. Ensures site GMP required procedures are in alignment and compliance with BMS Corporate Compliance and WWQ&C Headquarters Policies and Directives.
15. Ensures that deviations from procedures and specifications are investigated, resolved and documented, that corrective / preventive actions are identified and implemented to avoid the occurrence / recurrence of deviations and that no materials are released before the completion of the investigation.
16. Notifies the appropriate levels of management within Quality Operations Senior Management of significant quality issues in a timely fashion.
17. Assures that the Microbiology equipment (if required) and personnel are formally qualified before release testing of products/materials is performed.
18. Ensures that laboratory meets cycle disposition metrics, as well as Key Performance Indicators. Defines leading metrics and uses the Operational Excellence concepts to manage a lean operation.
19. Assures accuracy and completion of Annual Product Quality Review Report elements pertaining the laboratory inputs as established in products / systems schedule.
20. Approves or reject procedures affecting drug products, raw material, and USP water or packaging components.

BMSBL

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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.

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

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.

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