Associate Scientist

Shift Schedule

• Monday – Friday, Hybrid Day Shift, 9 a.m. – 5 p.m.
• Based on business needs, potential extended hours during off‑shift or weekend.

• Conduct thorough investigations (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 related inquiries.
• Handle complex issues and solve problems with minimal guidance.
• Serve as author or technical reviewer of departmental procedures as appropriate.
• 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.

• 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 or Infinity.
• Hands‑on experience preferred with CAR‑T or biopharmaceutical manufacturing and Quality Control.

• 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.
• 1 year of Cell therapy manufacturing operations or Cell therapy QC experience.
• 1 year of root cause analysis and CAPA determination experience.

• The incumbent will be working 50% to 90% of the time in an office environment.
• The incumbent will be working 10% to 20% of the time in a manufacturing and/or laboratory setting.
• The incumbent may travel between NJ sites for training, meetings or corporate events on occasion.
• The incumbent will need to have flexibility to work extended hours (>8 hours/day), weekend and/or holidays when required to meet deadlines.

Summit West - NJ - US
: $71,910 - $87,138

Additional compensation may include incentive cash and stock opportunities based on eligibility. Final compensation will be determined by experience.

• Health Coverage:
  Medical, pharmacy, dental and vision care.
• Well‑being 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, disability, life insurance and other protections.

Eligibility for specific benefits may vary by job and location. For more benefit details see .

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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