Bristol-Myers Squibb Company
Summit, NJ, United States
Sep 16, 2021
Dec 30, 2021
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.
This is a Sun - Wed 9pm-7am Night Shift
Purpose and Scope of Position:
The Supervisor, QC Flow Cytometry is responsible for all operational aspects of the QC Flow Cytometry department at the CAR T manufacturing facility during clinical and commercial phases. This department is responsible for Flow Cytometry based testing of in-process samples, final drug product testing, stability testing, Validation and requalification support, critical reagent testing and qualification, training and other critical support as needed. The Supervisor, QC Sample Management is responsible for continuously maintaining the GMP status of the QC Laboratory, applying and ensuring staff complies to EHS rules and safe work practices per applicable procedures, while still hand-on testing as needed.
Required Competencies: Knowledge, Skills, and Abilities
Extensive experience with flow cytometry and cell imaging, including flow related technologies related to analysis
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.
Duties and Responsibilities:
Manages all activities related to the QC Flow department including:
GMP release of in-process and drug product testing results.
Documentation of GMP release activities.
Method development and validation.
Oversight and qualification of contract testing laboratories.
Manages an 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.
Education and Experience
Bachelors’ degree required, preferably in Chemistry, Microbiology, or related science.
Advanced degree preferred.
3 years of relevant work experience required.
Experience auditing suppliers.
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.
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.
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 any part of the recruitment process direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Company: Bristol Myers Squibb
Req Number: R1546006
Updated: 2021-09-17 01:31:34.091 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.
Bristol-Myers Squibb Company
Website : http://www.bms.com