Associate Director, QC 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.

Purpose and Scope of Position:
The Associate 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.

Duties and Responsibilities:

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.
  

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

Performs other tasks as assigned.

Required Competencies and Experience:

• Bachelor’s degree required, preferable in Chemistry, Microbiology, or related science.

• Advanced degree preferred.

• 10 years of relevant work experience required.

• 4 years of leadership experience with direct reports required.

• 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.

Working Conditions:

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

• The incumbent may be required to gown for entry into the Aseptic Core and other supporting areas on an as-needed basis.

• The incumbent (or designee) will be expected to be on call to support manufacturing issues involving sampling and/or test excursions or questions during shift operations.

• Occasional travel may be required.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

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.

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.

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 if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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