Director, QC Microbiology, CTDO Quality Control

About the Role

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits.

This is work that transforms the lives of patients, and the careers of those who do it.

The Director, QC Microbiology is responsible for all operational aspects of the Quality Control Microbiology organization at the CAR T facility in support of stability programs, testing of raw materials, in-process controls, and final product samples, reading environment monitoring plates from routine and dynamic sampling from manufacturing area and supporting QC micro investigations.

• Advanced knowledge of cGMP, ISO, FDA, MHRA, PMDA, USP, PDA, JP, and EP regulations and guidelines as related to the manufacture of cell therapy products.
• Advanced verbal and written communication skills with the ability to tailor style for a wide variety of audiences.
• Ability to collaborate cross functionally to drive operational and quality excellence.
• Advanced organizational and time management skills.
• Demonstrated critical reasoning, problem solving, troubleshooting, investigation, and decision-making skills.
• Advanced teamwork and facilitation skills.
• Advanced mentoring and coaching, influencing, negotiating, and personal interaction skills.
• Requires strategic thinking and ability to work independently.
• Demonstrated leadership and management skills, including establishing strategic direction and goals, and guiding execution while fostering a team-based environment.
• Advanced knowledge of Quality Systems including SOPs, Change Controls, Deviations, CAPAs, and Risk Assessments.
• Ability to interpret and author general, technical, and complex business documents.
• Advanced knowledge and implementation of data integrity principles.
• Ability to represent the department in regulatory inspections.
• Requires strong qualitative training skills: responsiveness, enthusiasm, humor, sincerity, honesty, flexibility, and tolerance.
• Proficiency in MS Office applications.
• Ability to develop and manage a departmental budget.
• Ability to manage headcounts.
• Ability to lead projects to completion.
• Ability to design microbiology laboratory space and drive lean lab initiatives.
• Knowledgeable about micro assays including endotoxin, mycoplasma, rapid sterility method, automated EM plate reads.

Bachelor’s degree required, preferable in Chemistry, Microbiology, or related science. Advanced degree preferred. 10 years of relevant work experience required. Higher education may be counted towards work experience. Leadership experience with direct reports required.

• Manages all activities related to the Quality Control Microbiology department including:
  Stability testing, Raw material, in-process, and final product testing, Environmental Monitoring Method validations/maintenance, Metrics/data analysis, Investigations.
• Manages and develops direct reports including:
  Management and scheduling of personnel within the department to meet manufacturing and laboratory schedules and needs.
• Ensuring employees are properly trained and qualified to perform their assigned tasks, providing performance evaluations, and supporting career development of direct reports.
• Performs other tasks as assigned.

The incumbent will be required to work in office and laboratory environments. The incumbent may be…