Bristol Myers Squibb
Sr. Specialist, QC Analytical in Devens, MA
Bristol Myers Squibb, Harvard, Massachusetts, us, 01451
Sr. Specialist, QC Analytical in Devens, MA
Join to apply for the
Sr. Specialist, QC Analytical in Devens, MA
role at
Bristol Myers Squibb 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. 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. At
Bristol Myers Squibb
we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team. The
Senior Specialist, QC Analytical, Cell Therapy
is responsible for supporting Quality Control bioanalytical testing for method validation, critical reagent qualification, in-process, release, and stability testing of clinical and commercial cell therapy drug product. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot. Additionally, the QC Senior Specialist will assist with training and assay transfer. Responsibilities
Perform method transfer/validation and routine testing of in-process, final product, and stability samples. Use scientific principles to assist with analytical testing methods and the proper use of laboratory equipment. Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner. Review all data in accordance with applicable procedures and cGMP requirements. Anticipate and troubleshoot problems. Communicate effectively with management regarding task completion, roadblocks, and needs. Train new analysts to general job duties. Become a qualified trainer on assigned assays and deliver training to analysts, documenting training per procedural and cGMP requirements. Support document revision, project, CAPA, and investigation/deviation related tasks. Perform assigned tasks within a CAPA, deviation, or project. May lead projects and continuous improvement efforts. Perform other tasks as assigned. Knowledge and Skills
Hands on experience with various bioanalytical techniques (cell-based assays, flow cytometry, ELISA, qPCR) and scientific knowledge in the characterization, validation and transfer of bioanalytical methods. Ability to understand, follow, interpret and apply Global Regulatory and cGMP requirements accurately and completely. Strong technical writing skills. Strong problem-solving ability/mentality, technically adept and logical. Basic Requirements
Knowledge of science generally attained through studies resulting in a bachelor's degree in science, engineering, biochemistry or related discipline plus 1-3 years' experience in biopharmaceutical operations, or its equivalent is required. Working Conditions
Position may require working in Clean-Room manufacturing environment approximately 15% of the time. The remainder of work is performed in an office environment. 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. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. 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.
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Join to apply for the
Sr. Specialist, QC Analytical in Devens, MA
role at
Bristol Myers Squibb 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. 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. At
Bristol Myers Squibb
we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team. The
Senior Specialist, QC Analytical, Cell Therapy
is responsible for supporting Quality Control bioanalytical testing for method validation, critical reagent qualification, in-process, release, and stability testing of clinical and commercial cell therapy drug product. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot. Additionally, the QC Senior Specialist will assist with training and assay transfer. Responsibilities
Perform method transfer/validation and routine testing of in-process, final product, and stability samples. Use scientific principles to assist with analytical testing methods and the proper use of laboratory equipment. Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner. Review all data in accordance with applicable procedures and cGMP requirements. Anticipate and troubleshoot problems. Communicate effectively with management regarding task completion, roadblocks, and needs. Train new analysts to general job duties. Become a qualified trainer on assigned assays and deliver training to analysts, documenting training per procedural and cGMP requirements. Support document revision, project, CAPA, and investigation/deviation related tasks. Perform assigned tasks within a CAPA, deviation, or project. May lead projects and continuous improvement efforts. Perform other tasks as assigned. Knowledge and Skills
Hands on experience with various bioanalytical techniques (cell-based assays, flow cytometry, ELISA, qPCR) and scientific knowledge in the characterization, validation and transfer of bioanalytical methods. Ability to understand, follow, interpret and apply Global Regulatory and cGMP requirements accurately and completely. Strong technical writing skills. Strong problem-solving ability/mentality, technically adept and logical. Basic Requirements
Knowledge of science generally attained through studies resulting in a bachelor's degree in science, engineering, biochemistry or related discipline plus 1-3 years' experience in biopharmaceutical operations, or its equivalent is required. Working Conditions
Position may require working in Clean-Room manufacturing environment approximately 15% of the time. The remainder of work is performed in an office environment. 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. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. 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.
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