Associate Scientist

About the role

At Bristol Myers Squibb, you’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

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.
• Audit support during health authority inspections.
• Support deviation investigation defense during audits and site inspections related inquiries.
• Handle complex issues and solve problems with minimal guidance.
• Provide technical support for manufacturing investigations / CAPAs / Change Controls as needed.
• Employ lean manufacturing / six sigma principles to continuously improve products, processes and systems.

Requirements

• Requires a Bachelor’s Degree in science or engineering, preferably in Biochemistry, life sciences or related engineering discipline (advanced degree preferred).
• 1 year of Cell therapy manufacturing operations or Cell therapy QC experience.
• 1 year of root cause analysis and CAPA determination experience.

Qualifications

• 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.

Skills

• 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) or Infinity.

Benefits

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Pay

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience.

Schedule

Shift Available: Monday - Friday, Hybrid Day Shift, 9 a.m. - 5 p.m. Potential extended hours during off shift or weekend based on business needs.