Job Description

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.

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, environment monitoring, and manufacturing. This individual also plays a critical role in supporting facility design/modifications, the aseptic process validation program, operator qualification/requalification, and the gowning certification/recertification program.

* 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.

Qualifications:

* Bachelors degree required, preferable in Chemistry, Microbiology, or related science.
* Advanced degree preferred.
* 10 years of relevant work experience required.
* 6 years of 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

Plays a critical role in supporting overall facility operations including:

* Facility design and modifications
* Aseptic process validation
* Operator qualification
* Gowning certification
* Manufacturing support

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.

BMSCART

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.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or 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.