Senior Specialist, Quality Control

Responsibilities

• The person will serve as a Subject Matter Expert (SME) in the quality control group and will work along with analytical development team on method transfers from internal analytical team to external CDMO QC group
• The workstreams include technical GMP lead for oversight of external release and stability testing, method transfer troubleshooting, assisting in critical reagent management, execution of technical protocols
• Oversight of method qualification, validation at CDMO QC laboratories
• Support stability data analysis along with stability document reviews
• Maintain stability sample inventory and perform stability sample shipments to external contract laboratories and/or sample storage vendors, if needed
• Work with QA group on datasheet review, QC investigation, out of specification (OOS), CAPA, Change Controls, and/or Deviation reports
• Independently develop, author, revise, and execute SOPs, protocols, reports, and other related documents
• Perform internal stability testing for RNA related testing samples and formulated drug product samples, including compendial methods along with biophysical testing such as particle size, LNP encapsulation, etc.
• Support routine analytical testing for research program needs, such as with chromatography-based methods (HPLC) and/or biochemical assays such as ELISA assay
• Prepare the data packet for review and peer-review the data

Requirements

• Bachelor's degree required, preferably in a chemistry, life science, or related discipline with 5+ years relevant experience
• Past experience with quality control, preferably with focus on stability
• Hands-on experience on with at least one of the following analyses: mRNA, LNP, Potency assay, Flow Cytometry, PCR, ELISA, and/or HPLC is required
• Good understanding with cGMP, GDP and GLP regulations and guidelines
• General experience in data analysis and statistical evaluation/data trending
• Scientific knowledge and direct experience with analytical method transfer processes
• Advanced technical writing skills and problem-solving ability
• Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects
• Communicate effectively with peers, and demonstrate collaboration across different functional groups
• Detail-oriented in assay execution and documentation
• If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
• Compensation Overview:
• Cambridge - MA - US: $106,810 - $129,430
• Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
• Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing 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, short- and long-term disability, life insurance, accident insurance

Benefits

Additional Information

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 . Position Summary Bristol Myers Squibb at Kendall Square in Cambridge, MA is seeking a skilled QC specialist with GMP experience to join the Quality Control team to support the testing of novel RNA therapeutics. The successful candidate will help oversee external QC activities, assist with tech transfer to internal QC laboratories, and analyze internal routine testing samples.

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