Associate Director QC Microbiology

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us .

The Associate Director QC Microbiology is responsible for QC micro laboratory operations to ensure timely completion of testing (e.g., EM, drug product, raw materials) that is performed in compliance with regulatory agencies, cGMPs, and other company policies and procedures. Responsible for managing the QC Microbiology budget.

The Associate Director QC Microbiology is also responsible for on time closure of Lab investigations and associated CAPA’s. Oversee management and scheduling of multiple teams with varying functions and goals within the department.

The unique opportunity at this moment is to be able to focus on a project first and develop in that area as BMS builds its team.

This role is stationed in Leiden and reports to the Director QC.

Key Responsibilities

• Directs QC micro laboratory operations to ensure timely completion of testing (e.g., EM, drug product, raw materials) that is performed in compliance with regulatory agencies, cGMPs, and other company policies and procedures.
• Defines departmental roles and accountabilities. Hires, integrates, and develops high quality talent capable of delivering against the department’s goals and objectives.
• Establishes and communicates performance objectives for QC Microbiology staff that are consistent with the business unit and Quality goals.
• Defines and monitors performance measures, provides developmental feedback and coaching, and creates a collaborative environment that attracts, develops, and retains the best talent.
• Accountable for lifecycle management of microbiological methods and technology within the QC laboratory.
• Directs and participates in continuous improvement efforts to drive business efficiencies (e.g., TAT improvements, COGS reductions).
• Directs programs which assure the proper operation and maintenance of laboratory equipment and the timely data analysis and reporting of trends.
• Participates in the site team, which prepares for, hosts, and responds to regulatory inspections, reviews, and approvals of the facility and products.
• Accountable for on time completion of quality records within the QMS.
• Accountable for completion of Annual Product Quality Review and periodic investigation trending reports.
• Verifies compliance with applicable BMS Policies and Procedures and ensures consistency with other site procedures and/or specifications.
• Responsible for managing the QC Microbiology budget.
• Fosters collaboration and communication across site and network teams.
• Collaborates with managers across the QC network to harmonize best practices.
• Performs other tasks as required to support the QC micro laboratories.

Experience:

• Minimum of 10 years with a BS in Microbiology, Biology or related field with direct experience in biologics, cell therapy or sterile drug product microbial contamination control and 5+ years of leadership experience.
• Expert knowledge of common QC and environmental/clean utility monitoring procedures, techniques, and laboratory equipment/instrumentation, and the application and interpretation of GMP concepts and compendia requirements (e.g., USP, Ph Eur, CFR).
• Extensive and proven experience in regulatory inspections is essential.

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.

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/ eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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

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