Scientist, Investigations Team, S12 MSAT

Bristol Myers Squibb•Summit, NJ

2d•Hybrid

About The Position

Bristol Myers Squibb is reimagining the future of cell therapy and is looking for a Scientist/Investigator to lead manufacturing and QC investigation reports for S12 CAR T operations. This role involves conducting root cause investigations, interviewing personnel, testing and interpreting results, authoring reports, identifying CAPAs, and troubleshooting complex problems. The successful candidate will collaborate closely with various functional organizations, including Quality Assurance teams, and will work a hybrid day shift, Monday to Friday, 9 a.m. to 5 p.m.

Requirements

Working experience of deviation investigations utilizing root cause analysis tools.
Working experience in the CAPA process and ability to identify and verify effectiveness.
Technical writing skills and ability to collaborate effectively in cross functional teams.
Proven ability to accurately and completely understand, follow, interpret, apply Global Regulatory and cGMP requirements.
Ability to support health authority inspections.
Demonstrate advanced problem-solving ability / mentality, technical adeptness and logical thinking.
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.
Ability to communicate honestly, transparently and effectively with peers, department management and cross functional peers.
Ability to utilize electronic Quality systems such as eQRMs (Enterprise Quality and Regulatory Management system).
Ability to train new team members on the investigation process.
Requires a Bachelor’s Degree in science or engineering, preferably in Biochemistry, life sciences or related engineering discipline (advanced degree preferred). An equivalent combination of education and experience may substitute.
Minimum 3 years of cGMP environment.
1+ years of hands-on investigation experience.
1+ years of hands-on root-cause analysis experience.

Nice To Haves

Knowledge of data trending and tracking, including use of statistical analysis software a plus.
Hands on experience preferred with CAR-T or biopharmaceutical manufacturing and Quality Control.

Responsibilities

Conduct thorough investigations (OOS, OOT, Environmental Monitoring, deviations, etc.) utilizing root cause analysis tools.
Lead investigations and cross functional investigation teams, and close reports in a timely manner.
Perform GEMBA walks with stakeholders to better understand process steps, and evaluate Root Cause Analysis.
Work with functional teams to propose effective CAPAs, develop CAPA plans and assure CAPA effectiveness.
Assess potential impact and risk to product or process associated changes may have upon change implementation and develop an appropriate mitigation strategy.
May Initiate change control documentation.
Identify functional area SMEs to perform impact assessments as part of the change management process.
Ensure all investigations 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 deviation investigation defense during audits and site inspections for QC compliance related inquiries.
Handle complex issues and solve problems with minimal guidance.
Provide training to new investigations team members.
Serve as author or technical reviewer of departmental procedures as appropriate.
Support manufacturing and Quality Control testing of CAR- T products as needed.
Employ lean manufacturing / six sigma principles to continuously improve products, processes and systems.
Continuously support S12, living the “patients first” mission and fostering a “Right First Time” mindset.

Benefits

Medical, pharmacy, dental, and vision care.
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, 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
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.