Bristol Myers Squibb · 7 hours ago
Scientist/Engineer
Summit, NJ
Contract
Onsite
Mid Level
$50/hr - $55.94/hr
3+ years expBristol Myers Squibb is seeking a Scientist/Engineer responsible for leading manufacturing and QC investigation reports in support of CAR T operations. The role involves executing thorough root cause investigations, authoring reports, and interfacing with Quality Assurance teams to ensure compliance and effectiveness of corrective actions.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
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 promptly
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, living the patients first mission and fostering a Right First Time mindset
Qualification
Required
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
Knowledge of data trending and tracking, including use of statistical analysis software a plus
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 Bachelors Degree in science or engineering, preferably in Biochemistry, life sciences or related engineering discipline (advanced degree preferred)
Minimum 3 years of relevant work experience, preferably in a health authority-regulated environment
Preferred
Hands on experience preferred with CAR-T or biopharmaceutical manufacturing and Quality Control
Previous experience working in a biopharmaceutical manufacturing facility is preferred (CAR T a plus)
An equivalent combination of education and experience may substitute
Company
Bristol Myers Squibb
At Bristol Myers Squibb, we work every day to transform patients’ lives through science.
10001+ employees
H1B Sponsorship
Bristol Myers Squibb has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (247)
2024 (278)
2023 (231)
2022 (180)
2021 (181)
2020 (169)
Funding
Current Stage
Public CompanyTotal Funding
$29.32BKey Investors
Venrock
2025-11-05Post Ipo Debt· $5.74B
2024-02-14Post Ipo Debt· $13B
2023-10-30Post Ipo Debt· $4.5B
Leadership Team
Charles Bancroft
CFO
Cristian Massacesi
Executive Vice President, Chief Medical Officer and Head of Development
Recent News
2025-12-30
BioWorld Financial Watch
2025-12-29
2025-12-25
Company data provided by crunchbase