WORKING WITH US

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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. Read more: careers.bms.com/working-with-us.

POSITION SUMMARY

The Scientist QC Analytical is responsible for acting as a subject matter expert in method transfer/validation and analytical testing including complex troubleshooting, and training/mentoring. The Scientist is responsible for owning project, CAPA and deviation/investigation related tasks and authoring/reviewing technical documents.

QUALIFICATIONS & EXPERIENCE

• PhD in (bioanalytical) science preferred, master’s or bachelor’s degree in (bioanalytical) science with equivalent combination of work experience may be considered).
• 6+ years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment. (Demonstrated experience in cell and molecular biology techniques (e.g., cell-based assays, qPCR, ELISA, and aseptic technique).
• Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
• Demonstrated technical writing skills.
• Advanced knowledge of LIMS, Document Management and Quality Management systems preferred.
• High problem-solving ability/mentality, technically adept and logical.
• Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs.
• Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
• Strong mentoring, coaching, influencing, negotiating and personnel interaction skills.
  

  LI-Onsite

• Subject matter expert supporting method transfer/validation and routine analytical testing of in-process, final product, and stability samples.
• Perform review of testing data (e.g., data packets (in case of OOS), disposition of the Summary of Test Results (SOTR)).
• Anticipate and independently perform complex troubleshooting and problem solving.
• Perform data verification, data review and review of GMP documentation for multiple methods (general and complex) and/or products.
• Own project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts.
• May represent the department in regulatory inspections (internal and external audits).
• Train and mentor others on multiple QC test methods, processes, and procedures.
• Cross trained on multiple complex analytical methods and/or multiple products.
• Author and review/ revise technical documents such as test methods, SOPs, specifications and/or trend reports as appropriate.
• Perform other tasks as required to support the QC laboratories.