Associate Scientist
Listed on 2026-07-05
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Quality Assurance - QA/QC
Regulatory Compliance Specialist, Production QC/QA
Associate Scientist/Engineer – S12 CAR T Operations
The role is based in Summit West, New Jersey (Hybrid Day Shift, 9 a.m. – 5 p.m., Monday – Friday, with potential extended or weekend hours).
Responsibilities- Conduct thorough root‑cause investigations for environmental monitoring, deviations, and other quality issues.
- Lead cross‑functional investigation teams and close reports in a timely manner.
- Perform GEMBA walks with stakeholders to understand process steps and evaluate root causes.
- Develop and propose corrective and preventive actions (CAPA) and verify their effectiveness.
- Assess potential impact and risk to product or process changes, and develop mitigation strategies.
- Initiate change‑control documentation and identify subject‑matter experts for impact assessments.
- Ensure investigations are completed on schedule and notify stakeholders of any delays.
- Provide technical support for manufacturing investigations, CAPAs, and change controls.
- Support deviation investigation defense during audits and site inspections.
- Handle complex issues and solve problems with minimal guidance.
- Serve as author or technical reviewer of departmental procedures as appropriate.
- Apply lean manufacturing and Six Sigma principles to continuously improve products, processes, and systems.
- Support S12 operations with a “patients first” mindset and a “Right First Time” culture.
- Experience with deviation investigations using root‑cause analysis tools.
- Experience in the CAPA process, including verification of effectiveness.
- Technical writing skills and ability to collaborate in cross‑functional teams.
- Understanding of Global Regulatory and cGMP requirements.
- Ability to support health‑authority inspections.
- Knowledge of data trending and tracking, including use of statistical analysis software.
- Advanced problem‑solving ability and logical thinking.
- Excellent prioritization, timeline management, and adaptability to changing priorities.
- Effective communication with peers, management, and cross‑functional stakeholders.
- Experience using electronic Quality systems such as eQRMs or Infinity.
- Hands‑on experience with CAR‑T or biopharmaceutical manufacturing and Quality Control (preferred).
- Bachelor’s Degree in science or engineering (Biochemistry, life sciences, or related engineering discipline). An advanced degree is preferred.
- 1 year of Cell Therapy manufacturing operations or QC experience.
- 1 year of root‑cause analysis and CAPA determination experience.
- 50% to 90% of time in an office environment.
- 10% to 20% time in manufacturing and/or laboratory settings.
- Occasional travel between NJ sites for training, meetings, or corporate events.
- Flexibility to work extended hours (>8 hours/day), weekends, and holidays when required.
Summit West – NJ – US: $71,910 – $87,138 per year (starting range). Additional incentive cash and stock opportunities may apply. Final pay determined based on demonstrated experience.
Benefits- Health Coverage:
Medical, pharmacy, dental, and vision care. - Well‑being Support: BMS Well‑Being Account, BMS Living Life Better, Employee Assistance Programs.
- Financial Well‑being: 401(k) plan, disability insurance, life insurance, supplemental health insurance, and legal support.
- Work‑life benefits:
Paid time off, flexible time off, national holidays, and global shutdown. - Additional time off options for eligible employees: paid sick time, volunteer days, summer hours flexibility, leaves for personal or medical reasons.
BMS is an equal opportunity employer. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations, and ongoing support in their roles. Applicants may request accommodation adjustments prior to accepting an offer. Contact for assistance.
Application InformationThe posting is open; no indication that the position is no longer accepting applications.
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