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. About Bristol-Myers Squibb
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 Data Management Scientist is responsible for supporting data management related activities within the S12 Quality Control department in direct support of clinical and commercial CAR T manufacturing activities. This individual will focus on the timely and quality delivery of data review, storage in physical and electronic binders.
This includes the ability to interface with cross functional groups, independently perform tasks, ensure completion of all testing documentation and filing in the patient binders and CoA issuance. Additionally, the QCDM Scientist will be responsible for continuous improvement of the data management processes, Right First-Time initiatives, and streamlined disposition of C AR T drug products from the Summit West - S12 Facility. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
- Advanced Working experience in data management in a cGMP environment.
- Ability to keep accurate records, strong attention to details, follow instructions, and comply with company policies.
- Advanced ability to accurately and completely understand, follow, interpret and apply Global
Regulatory and cGMP requirements.
Education and Experience:
- Advanced a bi li t y to communicate effectively with team members, department management and cros s -functional peer s .
- Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.
- Good interpersonal skills are a must.
- Advanced technical writing skill s .
- Advanced problem - solving ability/mentality, technically adept and logical.
- Ability to represent the interests of the S12 QC organization on cross - functional team s .
- experience supporting health authority inspections.
- Knowledge of data trending and tracking, including use of statistical analysis software a plus.
- Ability to set priorities, manage timelines and effectively react/manage changing priorities.
- Ability to work with management ( global and site ) and support corporate and departmental goals .
- Abi li t y to communicate honestly, transparently and effectively with peers, department management and cros s functional peer s .
- Ability to utilize electronic Quality systems such as eQRMs (Enterprise Quality and Regulatory Management system).
- Ability to mentor junior associates to foster and develop their expertise.
DUTIES AND RESPONSIBILITIES:
- Requires a bachelor's degree in science, preferably in Biochemistry, Immunology, Molecular and Cellular Biology, Biology, Microbiology or related discipline ( advanced degree preferred).
- 7-10 y e ars o f relevant work experience, preferably in a health authority regulated environment.
- Previous experience in a gene or cell therapy facility is preferred (CAR-T a plus).
- An equivalent combination of education and experience may substitut e.
WORKING CONDITIONS (US Only):
- Generate patient binders both physical and electronic according to the manufacturing schedule
- Support Data review of QC Data as needed
- Ensure all required data are reported and reviewed by the QC operations teams according to the corresponding procedures and that these milestones are completed for on time disposition of CAR T drug products.
- Ensure binder completion (physical and electronic), form reconciliation, CELabs review completion prior to CAR T drug product lot disposition.
- Issue, review and approve CoAs for CAR T drug product lots.
- Participate in data integrity and process mapping projects.
- Support CAPAs, NOE creation and investigations.
- A ctively participate in strategic planning and coordination activities with QC scheduling and planning, QA Disposition and Global Supply Chain to ensure on time disposition of cellular drug product lots.
- Ensure that all interim dispositions assessments are completed for deviations impacting cellular drug product lots prior to their target site disposition dates.
- Be Single Point of Contact for QC Data
- Initiate change control documentation and assist other QC functional groups with change management documentation.
- Identify functional area SMEs to perform impact assessments as part of the change management process.
- Ensure all investigations, CAPAs and change controls are completed in a timely manner. Notify stakeholders of any delays in a timely manner.
- Provide technical support for manufacturing investigations / CAPAs / change controls as needed.
- Support QC during audits and site inspections for QC compliance related inquiries.
- Handle complex issues and solve problems with minimal guidance.
- Provide mentorship, guidance and training to junior t eam members.
- Serve as author or technical reviewer of departmental procedures as appropriate.
- Employ lean manufacturing / six sigma principles to continuously improve products, processes and systems.
- Continuously support QC, living the "patients first" mission and fostering a "Right First Time" mindset.
- The incumbent will be working 70 % to 90% of the time in an office environment.
- The incumbent will be working 10% to 30% of the time in a manufacturing and/or laboratory setting.
- The incumbent may travel between NJ sites for training, meetings or corporate events on occasion.
- The incumbent will need to have flexibility to work extended hours (>8 hours/day), weekend and/or holidays when required to meet deadlines.
This job description is intended to describe the general nature and level of work being performed b y th e perso n assigne d t o thi s position . Th e primar y 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 seconda r y 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 based on business needs.
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.