Director, QC Microbiology, CTDO Quality Control
Bristol Myers Squibb
Summary
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.
Job description
Purpose and Scope of Position
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.
Duties and Responsibilities
- 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, and investigations.
- Manages and develops direct reports including management and scheduling of personnel within the department to meet manufacturing and laboratory schedules and needs.
- Ensures 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.
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 issues involving test excursions or questions during shift operations. Occasional travel may be required.
Requirements
- Bachelor's degree required, preferably in Chemistry, Microbiology, or related science
- Advanced degree preferred
- 10 years of relevant work experience required
- 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
- 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
Benefits
- Medical, Dental & Vision
- Life & Disability Insurance
- Retirement Benefits
- Flexible Time Off
- 11 Paid Company Holidays
- Paid Sick Leave
- Volunteer Days
- Summer Hours Flexibility
- Parental Leave
- Global Shutdown
Company overview
Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Founded in 1887 and headquartered in Princeton, New Jersey, the company operates with a unique BioPharma strategy that combines the reach and resources of a major pharmaceutical company with the entrepreneurial spirit and agility of a biotech firm. BMS focuses on transformative therapies in key therapeutic areas including oncology, hematology, immunology, cardiovascular disease, and fibrosis. The company has built a sustainable pipeline of potential therapies and leverages translational medicine and data analytics to deliver the right medicine to the right patient at the right time. With over 10,000 employees worldwide, Bristol Myers Squibb maintains a strong commitment to scientific excellence, patient-centric innovation, and global health equity through its foundation. The company's portfolio includes groundbreaking treatments such as Opdivo (nivolumab) for cancer, Eliquis (apixaban) for cardiovascular conditions, and Orencia (abatacept) for autoimmune diseases, among others.