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.
Position Title:
Sr. Supervisor, QC Materials
Direct Manager:
Associate Director, QC Systems and Services
Division:
CTDO Quality Control
Direct Reports:
Yes
Location:
Summit West, S-12
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
PURPOSE AND SCOPE OF POSITION:
The Sr Supervisor, QC materials (Critical Reagents) is responsible for all operational aspects of the QC critical reagents department at the CAR T manufacturing facility during clinical and commercial phases. This department is responsible for testing of critical reagent testing, qualification and other critical support as needed. The Supervisor 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.
This position has both supervisory and testing responsibilities and is responsible for the management of the directly assigned QC personnel and plans the activities for the QC personnel involved in critical reagent testing. This includes the review and approval of QC generated raw data and analytical test results, handling of deviations, CAPAs, laboratory investigations and change controls. This requires the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot. Additionally, when needed, this position will be able to assist with training and assay transfer.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
- Experience as a team leader with proven leadership skills.
- Advanced hands-on experience with various analytical techniques including but not limited to Flow cytometry (FACS), qPCR and scientific knowledge in the characterization of pharmaceutical products.
- 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.
Education and Experience:
- Bachelors’ degree required, preferably in Chemistry, Microbiology, or related science.
- Advanced Degree preferred.
- 5-8 years of relevant work experience, preferably in a GMP regulated environment.
- An equivalent combination of education and experience may substitute.
DUTIES AND RESPONSIBILITIES:
Manages all activities related to the QC critical reagents department including:
- Schedule activities and tests
- Take a leadership role, as required, for projects.
- Coordinate and Perform testing of critical reagents.
- Utilize scientific principles to assist in analytical testing methods and the proper use of laboratory equipment.
- Prepare and present continuous improvement projects to management.
- Comprehensive understanding of regulatory guidelines and can independently develop, write and execute methods, protocols, reports and other related documents.
- Complete all work in a timely manner.
- Review all data in accordance with applicable procedures and cGMP requirements.
- Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
- Support document revision, project, CAPA, and investigation/deviation tasks.
- Participate in complex projects and continuous improvement efforts.
- Draft and review technical documents, such as SOPs and protocols/reports.
- Communicate effectively with management regarding task completion, roadblocks, and needs
- GMP release of in-process and drug product testing results.
- Documentation of GMP release activities.
- Method transfer development and validation as needed.
Manages and develops direct reports including:
- Management and scheduling of personnel within the department to meet required 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.
- Mentor, coach and develop direct reports
Performs other tasks as assigned.
WORKING CONDITIONS (US Only):
- 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 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.
If you want to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients’ lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.
BMSCART
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.
