Bristol Myers Squibb · 1 day ago
Scientist, Investigation Team
Summit West - NJ - US
Full-time
Onsite
Mid, Senior Level
$82K/yr - $100K/yr
3+ years expBristol Myers Squibb is a leading company in cell therapy, dedicated to transforming patients' lives through science. The Scientist in the Investigation Team will be responsible for leading manufacturing and quality control investigation reports, executing thorough root cause investigations, and interfacing with various functional organizations to ensure compliance and effectiveness in operations.
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 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
Qualification
Required
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 higher education and experience may substitute
Minimum 3 years of investigations experience within a cGMP facility
Working experience of deviation investigations utilizing root cause analysis tools
Minimum 3 years of Manufacturing or Quality experience within a cGMP facility
Advanced working experience of deviation investigations utilizing root cause analysis tools
Working experience in the CAPA process and ability to identify and verify effectiveness
Advanced technical writing skills, and capability to review, improve, and approve investigation reports from more junior team members
Capability to kickoff and lead limited duration investigation teams, to ensure timely completion of more complex investigations requiring scientific work outside of S12 site
Proven ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements
Experience supporting 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 and mentor junior associates to foster and develop their expertise
Ability to support health authority inspections
Preferred
Hands on experience preferred with CAR T or biopharmaceutical manufacturing and Quality Control
Knowledge of data trending and tracking, including use of statistical analysis software a plus
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.
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
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.
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
2026-01-08
2026-01-07
2026-01-07
Company data provided by crunchbase