Director, QC Microbiology, CTDO Quality Control

Biopharma Careers; Summit West (CA); On-site; USD 185,000 - 224,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible Time Off

Vacation + holidays

Global Shutdown

Job summary

Bristol Myers Squibb is seeking a Director of QC Microbiology for the CAR T facility in Summit West, NJ. You will lead the department’s stability testing, raw material and product testing, environmental monitoring, and investigations to ensure Q, regulatory, and quality standards are met.

Join a purpose-driven, collaboration-focused team with opportunities to guide strategy, mentor direct reports, and drive lean lab initiatives in a high-impact cell therapy setting.

Qualifications

• Bachelor’s degree in Chemistry or Microbiology required; advanced degree preferred.
• 10 years of relevant work experience required; leadership of direct reports.
• Experience with cGMP, regulatory inspections, and quality systems.
• Strong cross-functional collaboration and leadership capabilities.
• Experience with environmental monitoring and QC testing is a plus.

Responsibilities

• Oversee stability testing, raw material, in-process, and final product testing.
• Manage environmental monitoring and method validations/maintenance.
• Lead metrics/data analysis and investigations.
• Develop, coach and evaluate direct reports; ensure staffing meets needs.
• Represent department in regulatory inspections and audits.

Skills

cGMP knowledge

Leadership

Problem solving

Quality Systems

Regulatory inspections

Data integrity

Budget management

Cross-functional collaboration

Education

Bachelor's degree in Chemistry or Microbiology

Advanced degree preferred

Tools

MS Office applications

Job description

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 in Chemistry, Microbiology, or related s cience.

Advanced d egree preferred.

10 y e ars o f 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.

WORKING CONDITIONS

Th e incum bent will be required to work in office and laborato r y environments.

T he incumbent may be required to gown for entry into the Aseptic C ore and other supporting areas on an a s- needed basis.

The incumbent (or designee) will be expected to be on call to support issues in v olving test excursions or q u estions during shift operation s.

Occasional travel may be required.

Compensation Overview

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.

Summit West - NJ - US: $184,550 - $223,634

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 at https://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 [e-mail] . 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.

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 [e-mail] 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