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Director QC Microbiology

Bristol-Myers Squibb
Summit, New Jersey, US
Closing date
Sep 19, 2023

View more

Consultancy/Private Sector
Conservation science
Salary Type
Employment Type
Full time
**Working with Us**

Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: .

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.


+ 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.

**Knowledge & Skills:**

+ 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.

**Basic Requirements:**

+ Bachelors degree required, preferable in Chemistry, Microbiology, or related science.

+ 10 years of relevant work experience required. Higher education may be counted towards work experience.

+ 5 years of Leadership experience with direct reports required.

**Preferred Requirements:**

+ Advanced degree in Chemistry, Microbiology, or related science.

+ Cell and gene therapy experience.


_If you come across a role that intrigues you but doesnt perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career._

**Uniquely Interesting Work, Life-changing Careers**

With a single vision as inspiring as Transforming patients lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

**On-site Protocol**

Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

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 . Visit ( eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

**Company:** Bristol Myers Squibb

**Req Number:** R1572558

**Updated:** 2023-09-15 04:00:52.023 UTC

**Location:** Summit,New Jersey

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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