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Senior Specialist, QC Molecular

  • Anywhere

Company :
Bristol-Myers Squibb

Location :
Devens, Massachusetts

Expiry Date :
Tue, 15 Dec 2020 23:59:59 GMT

Apply Job :
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Description :
At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through 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. Job Summary Bristol Myers Squibb is seeking a Senior Specialist for QC Molecular at the Cell Therapy Facility (CTF) in Devens, MA. The Senior Scientist is responsible for performing as a subject matter expert in the completion of the Quality Control bioanalytical testing or data review in direct support of clinical and commercial manufacturing activities. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot. Additionally, this position will be responsible for training and may participate in assay transfer. The Senior Specialist role is stationed in Devens, MA and reports to the Head of QC Molecular for the Devens CTF. Job Responsibilities – Perform testing of the in-process, final product, and stability samples. – Utilize advanced scientific principles to assist bioanalytical testing and the proper use of laboratory equipment. – Capable of handling complex issues and solving problems with minimum guidance. – Comprehensive understanding of regulatory guidelines and can independently develop, write and execute methods, protocols, reports and other related documents. – Train new analysts to general job duties. – Complete necessary training to become a qualified trainer. – Perform training effectively. – Document training per procedural and cGMP requirements. – Support document revision, project, CAPA, and investigation/deviation tasks. – Perform assigned tasks within a CAPA, deviation, or project – Participate in complex projects and continuous improvement efforts. – Take a leadership role, as required, for projects. – Draft and review technical documents, such as SOPs and protocols/reports. – Communicate effectively with management regarding task completion, roadblocks, and needs. – Demonstrate initiative, courage, and continuous improvement throughout investigation/corrective action lifecycles. Qualifications and Education Requirements – Advanced hands on experience with various bioanalytical techniques including ELISA, qPCR, FACS 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. – Ability to work with management locally and globally. – Advanced ability to communicate effectively with peers, department management and cross-functional peers. – Bachelors degree required, preferably in Science. – Advanced Degree preferred. – 7-10 years of relevant work experience, preferable in a regulated environment. If you want to challenge yourself, accelerate your career, and give new hope to patients, theres 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. BMSCART 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.