Bristol Myers Squibb
Healthcare
Sr.Specialist,QualityAssuranceDrugProductDispositionCellTherapy
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“Sr. Specialist, Quality Assurance Drug Product Disposition Cell Therapy at Bristol Myers Squibb. Skills: Quality Assurance, Drug product release, cGMP. Support quality and disposition activities. Aid in routine drug product release”
What You'll Achieve.
Timely release of drug product
Industry & Context.
Troubleshoot issues; Resolve problems
Sunday-Wednesday shift, 10 hour day shifts
What They're Looking For.
Must Have
4 years directly relevant experience, B.S. in science, engineering, biochemistry, Equivalent education and experience considered
Nice to Have
Previous quality experience preferred
What You'll Do.
Support quality and disposition activities
Aid in routine drug product release
Assure manufactured product quality
Prepare deliverables for product release
Maintain and review batch record documentation
Author or review departmental SOPs
Develop Standard Operating Procedures
Develop business processes
Prepare documentation for drug product disposition
Verify accuracy of drug product documentation
Perform review of batch genealogy
Update lot status in quality systems
Coordinate with stakeholders to troubleshoot
Provide guidance to less experienced staff
Own Quality System records
Perform Release for Infusion
Calculate patient dosage
How You'll Work.
Team & Collaboration
Internal and external stakeholders
Full Job Description
**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. 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](https://careers.bms.com/working-with-us). The Sr. Specialist, Quality Assurance Drug Product Disposition, Devens Cell Therapy role is responsible for supporting quality and disposition activities at the Devens, MA Cell Therapy manufacturing facility, in accordance with BMS policies, standards, procedures and Global cGMP. This role will aid in the routine and timely release of drug product and assure the quality of manufactured products is in compliance with all applicable regulations and guidelines. **This individual will support the Sunday-Wednesday shift and be responsible for working 4 days a week with 10 hour day shifts.** **** Functional responsibilities include preparing deliverables for product release within the inventory management system (SAP) or Cell Health Intelligence Platform (CHIP), ensuring accurate and timely maintenance and review of batch record documentation and authoring or reviewing departmental SOP’s and Work Practices. * Develops and maintains Standard Operating Procedures, training, and business processes supporting drug product disposition
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