Director, QC Microbiology, CTDO Quality Control
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.
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.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
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
Education and Experience:
Bachelor’s degree required, preferable inChemistry, Microbiology, or related science.
Advanceddegree preferred.
10 years of relevant work experience required. Higher education may be counted towards work experience.
Leadership experience with direct reports required.
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
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.
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 AsepticCore andother 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.
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.
We hire for skills and capabilities, not just credentials - if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
Compensation Overview:
Summit West - NJ - US: $184,550 - $223,634The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully - carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.
Benefits:
Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans - including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
U.S.-based job seekers can explore full benefit offerings athttps://careers.bms.com/benefits
How We Work
Where you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
Supporting People with Disabilities
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 [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If this posting is missing required information required by local law or incorrect, contact BMS at [email protected] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.
R1606133 : Director, QC Microbiology, CTDO Quality Control