Bristol-Myers Squibb
Senior Specialist, QC Analytical
Bristol-Myers Squibb, Summit, New Jersey, us, 07902
Senior Specialist, QC Analytical
Working with UsChallenging. 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.The Senior Specialist position is responsible for performing routine testing of in-process, final product, and stability samples in accordance with BMS policies, standards, procedures, and Global Regulatory and cGMP requirements to support the Quality Control Analytical department in the Bristol Myers Squibb (BMS) CAR T Manufacturing facility located in Summit, NJ. Additionally, this role performs data review for general and complex methods to support final drug product release. This position requires high problem-solving skills/mentality with minimal guidance, the ability to interface with multiple cross-functional groups, as well as the ability to work in a fast-paced team environment.Shift Available:Wednesday - Saturday, Onsite Day Shift, 8 a.m. - 6 p.m.Responsibilities:Perform method transfer/validation and routine testing of in-process, final product, and stability samples.Anticipate and perform routine troubleshooting and problem solving with minimal guidance.Perform data verification, data review and review of GMP documentation for general and complex methods.Perform document revision, project, CAPA and deviation/investigation related tasks and/or continuous improvement efforts.Train and mentor others on QC test methods, processes, and procedures.Perform other tasks as assigned.Knowledge & Skills:Ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements.Demonstrated technical writing skills.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.Advanced knowledge of LIMS, ELN and laboratory data analysis systems preferred.Basic Requirements:Bachelor’s degree or equivalent required, preferably in Science. Advanced degree preferred.4+ years of relevant analytical testing with strong pipetting experience.1-3 years of experience with flow cytometry or molecular techniques.Preferred Requirements:QC lab testing highly desired.LIMS experience.On-site ProtocolBMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/.
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Working with UsChallenging. 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.The Senior Specialist position is responsible for performing routine testing of in-process, final product, and stability samples in accordance with BMS policies, standards, procedures, and Global Regulatory and cGMP requirements to support the Quality Control Analytical department in the Bristol Myers Squibb (BMS) CAR T Manufacturing facility located in Summit, NJ. Additionally, this role performs data review for general and complex methods to support final drug product release. This position requires high problem-solving skills/mentality with minimal guidance, the ability to interface with multiple cross-functional groups, as well as the ability to work in a fast-paced team environment.Shift Available:Wednesday - Saturday, Onsite Day Shift, 8 a.m. - 6 p.m.Responsibilities:Perform method transfer/validation and routine testing of in-process, final product, and stability samples.Anticipate and perform routine troubleshooting and problem solving with minimal guidance.Perform data verification, data review and review of GMP documentation for general and complex methods.Perform document revision, project, CAPA and deviation/investigation related tasks and/or continuous improvement efforts.Train and mentor others on QC test methods, processes, and procedures.Perform other tasks as assigned.Knowledge & Skills:Ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements.Demonstrated technical writing skills.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.Advanced knowledge of LIMS, ELN and laboratory data analysis systems preferred.Basic Requirements:Bachelor’s degree or equivalent required, preferably in Science. Advanced degree preferred.4+ years of relevant analytical testing with strong pipetting experience.1-3 years of experience with flow cytometry or molecular techniques.Preferred Requirements:QC lab testing highly desired.LIMS experience.On-site ProtocolBMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/.
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