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Associate Scientist

$71.91k - $87.14k

Bristol Myers Squibb

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. Responsibilities 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. Knowledge & Skills 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. Minimum Requirements 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. Working Conditions 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. Compensation Overview 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. Benefits Offerings 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 . Candidate Rights / EEO Statement BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Supporting People With Disabilities BMS is dedicated to ensuring people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations and ongoing support in their roles. Applicants can request accommodations prior to accepting a job offer at View email address on click.appcast.io. Data Protection We will never request payments, financial information or social security numbers during our application or recruitment process. Learn more at . Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. #J-18808-Ljbffr Bristol Myers Squibb

Vacancy posted 2 days ago
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