Scientist, CTTO Analytical Testing

Bristol Myers Squibb•Summit, NJ

1d•Onsite

About The Position

The Cell Therapy Technical Operation (CTTO) Scientist is responsible for supporting the analytical testing at the Analytical Testing group within CTTO during the commercial phase. This group focuses on flow-cytometry and molecular-based sample testing for process robustness, stability, comparability, validation, training, technical transfer, and other critical support. The role requires the ability to interface with multiple cross-functional stakeholders, independently perform tasks, interpret results, and troubleshoot.

Requirements

Advanced hands-on experience with various analytical techniques including flow-cytometry, molecular techniques and scientific knowledge in the characterization and transfer of pharmaceutical products.
Advanced ability to accurately understand, follow, interpret, and apply global regulatory and cGMP requirements.
Advanced technical writing skills, problem-solving ability/mentality, technically adept and logical thinking.
Ability to represent the interests of the group on cross-functional teams.
Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.
Ability to work with management locally and globally.
Advanced ability to communicate effectively with peers, department management and cross-functional peers.
Bachelor’s degree required, preferably in science.
BS degree with minimum of 5 years of relevant experience, or MS degree with minimum 2 years of relevant experience, or PhD degree with minimum of 1 years of relevant experience in analytical development, analytical testing, and/or analytical method technical transfer, preferably in a regulated environment.

Nice To Haves

Advanced degree preferred.
Demonstrated experience working with polychromatic flow-cytometry panels, flow-cytometry data analysis, ELISA and qPCR preferred.

Responsibilities

Perform cell based in-vitro flow instrument, ELISA, qPCR assays.
Perform testing on process characterization, comparability, stability and investigational samples.
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 reviews in accordance with required release timelines of reagents.
Manage, and support moderately complex projects, analytical technology transfer activities, and continuous improvement efforts.
Develop, write, and execute methods, protocols, reports and other related technical documents, such as SOPs, with a comprehensive understanding of regulatory guidelines.
Manage, and support document writing, revision, project, CAPA, and investigation/deviation tasks.
Effectively train new analysts on analytical methods, instrument operation, and general job duties.
Complete necessary training to become a qualified trainer.
Manage and oversee junior scientist.
Communicate effectively with peers, and demonstrate teamwork, with regards to review of results and corrections required.
Demonstrate initiative, courage, and continuous improvement throughout investigation/corrective action lifecycles.
Communicate effectively with management regarding project updates, task completion, roadblocks, and needs.
Handle complex issues and solve problems with only general guidance.
Complete all work in a timely manner.

Benefits

Medical, pharmacy, dental, and vision care.
Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Flexible time off (unlimited, with manager approval) for US Exempt Employees.
11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees).
160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays for Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees.
Unlimited paid sick time.
Up to 2 paid volunteer days per year.
Summer hours flexibility.
Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs.
An annual Global Shutdown between Christmas and New Years Day.