Scientist, CTTO Analytical Testing

Bristol Myers Squibb • Summit, NJ

2d

About The Position

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

Requirements

• Bachelor’s degree required, preferably in science, advanced degree preferred.
• 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.
• Demonstrated experience working with polychromatic flow-cytometry panels, flow-cytometry data analysis, ELISA and qPCR preferred.
• 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 biohazardous materials, including chemical agents up to six (6) hours per day.
• 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.

Nice To Haves

• 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.
• Utilize scientific principles to lead and support troubleshoot analytical testing methods and the proper use of laboratory equipment.
• Lead, manage, and support moderately complex projects, analytical technology transfer activities, and continuous improvement efforts.
• Comprehensive understanding of regulatory guidelines and can independently develop, write, and execute methods, protocols, reports and other related technical documents, such as SOPs.
• Lead, 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.
• Capable of handling complex issues and solving problems with only general guidance.
• Complete all work in a timely manner.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 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.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include 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 and an annual Global Shutdown between Christmas and New Years Day.
• All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level