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Title: Associate QC Scientist, Cell Therapy Bioanalytics, CAR-T Location: Warren, NJ The
QC Associate Scientist is responsible for supporting Quality Control bioanalytical testing for release of clinical and commercial products . This includes 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.
Qualifications & Experience
- Bachelor's degree required, preferably in Science.
- 3-5 ye ars o f relevant work experience, preferably in a regulated environment.
- An equivalent combination of education and experience may substitut e.
- Hands-on experience with various bioanalytical techniques in Flow. Experience with Elisa and qPCR is a plus.
- Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements .
- Technical writing skill s .
- Problem-solving ability/mentality, technically adept and logical.
- Ability to represent the interests of the gro u p on cross - functional team s .
- Ability to set priorities of the group and manage timelines.
- Ability to work with management locally and globall y .
- Abi lit y to communicate effectively with peers, department management and cros s -functional peer s .
Key Responsibilities Perform testing of in-process, final product, and stability samples.
- Utilize scientific principles to assist in analy tical testing methods and the proper use of laborato r y equipment.
- Anticipate and troubleshoot problems.
- Recommend corrective actions and participate in the development of best practices.
- 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.
- Work and communicate effectively within the team to ensure timelines are met.
Perform peer review of testing data.
- 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.
- Complete all review in accordance with required release timelines.
- Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and corrections required.
Train new analysts to general job duties.
- Complete necessary training to become a qualified trainer.
- Perform training effectively.
- Document training per procedural and cGMP requirements.
Support document revision, project, CAPA, and investigation/deviation related tasks.
- Perform assigned tasks within a CAPA, deviation, or project
- Draft and review technical documents, such as SOPs and protocols/reports.
- Communicate effectively with management regarding task completion, roadblocks, and needs.
- Demonstrate initiative, courage, and continuous improvement throughout investigation/corrective action lifecycles.
- Performs other tasks as a s signed.
Working Conditions
- The incumbent should be able to distinguish colors and possess correctable vision to 20/20, annual eye exam is required.
- The incumbent must analyze numerical values on a daily basis.
- The incumbent will be working a laboratory setting up to six ( 6) hours per day.
- The incumbent will be working around bio hazardous materials, including chemical agents, up to six ( 6) hours per day.
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If you come across a role that intrigues you but doesn't 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 BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
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 adastaffingsupport@bms.com . Visit careers.bms.com/ 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.
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