Bristol Myers Squibb Manager, Scientist, QC Molecular in Devens, Massachusetts
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Bristol Myers Squibb is seeking a QC Scientist for QC Molecular at the Cell Therapy Facility (CTF) in Devens, MA. The QC Scientist is responsible for performing as a subject matter expert in the completion of QC bioanalytical testing or data review 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 Scientist will be responsible for training and assay transfer. The QC Scientist role is stationed in Devens, MA and reports to the Head of QC Analytical for the Devens CTF.
Subject matter expert supporting 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.
Subject matter expert for training 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.
Independently develop, write, and execute methods, protocols, reports, and other related documents aligned with regulatory and corporate guidelines.
Own and evaluate relevant change controls, investigations, deviations, CAPAs.
Lead complex projects and continuous improvement efforts.
Prepare and present continuous improvement projects to management.
Demonstrate initiative, courage, and continuous improvement throughout investigation/ corrective action lifecycles.
Perform other tasks as assigned.
Support for QC and manufacturing operations may include shift coverage consisting of on call, shift, and/or weekend coverage.
Qualifications and Education Requirements
Bachelor’s degree required, preferably in Science. Advanced degree preferred.
6+ years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.
Advanced hands on experience with various bioanalytical techniques (cell based assays, ELISA, qPCR) and scientific knowledge in the characterization, validation and transfer of bioanalytical methods.
Advanced ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
Advanced technical writing skills.
Advanced problem-solving ability/mentality, technically adept and logical.
Ability to represent the interests of the group on cross-functional teams.
Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.
Advanced ability to communicate effectively with peers, department management and cross-functional peers. Ability to work with management locally and globally.
Working knowledge of LIMS.
If you want to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients’ lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Company: Bristol Myers Squibb
Req Number: R1532843
Updated: 2021-04-16 01:12:13.217 UTC
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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