Sr. Manager, Process Engineer/Scientist Cell Therapy
Summit, New Jersey
Expiry Date :
Mon, 05 Apr 2021 23:59:59 GMT
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Sr. Manager, Process Engineer/Scientist – Cell Therapy 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. Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS’s continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible. We are looking for a Sr. Manager, Process Engineer/Scientist to join our Vector and Gene Delivery in the Global Manufacturing & Technology group here at Bristol Myers Squibb. We are looking for a Senior Manager, Process Engineer/Scientist to join our Vector and Gene Delivery in the Global Manufacturing & Technology group here at Bristol Myers Squibb. The successful candidate will lead efforts related to transfer of vector manufacturing technologies from process development to GMP manufacturing and have responsibilities of lifecycle management thereafter. The Senior Engineer/Scientist will be responsible for overseeing the transfer of technologies, including cross-departmental collaboration to enable facility fit, development of process documentation (Batch Records, Forms, etc.), training of personnel, change control ownership, and other quality system related deliverables, as well as development and support of PPQ strategies and commercial manufacturing. This person may be responsible for and support processes from early clinical phase development. This person will collaborate across all CMC functional areas to insure project advancement, rapid and best in class execution, and communication of challenges/opportunities. The Senior Engineer/Scientist will play a key role in product lifecycle management, including strategic development, characterization, commercialization, and evolution of cell therapy products. This position reports to the Director of Vector and Gene Deliver MS & T – Summit, NJ Duties/Responsibilities: The initial focus area for this position is to support a second-generation vector process, using innovative suspension cell technology, to a commercial manufacturing facility product Lead process and technology transfers, change management, and technical process support for vector process intermediates for cell therapy drug product manufacturing Lead development and establishment of process control strategies including execution of process risk assessments, development of range justifications, comparability assessments, and development of continued process verification strategy Develop, understand, and manage tools and templates to quantify impact and criticality for parameters and attributes within manufacturing unit operations. Author and review regulatory filings across product lifecycle Perform and support data monitoring of manufacturing processes to understand process capability, troubleshoot investigation-driven events Identify opportunities for process improvements, make formal recommendations, and drive improvements to completion Support design activities for clinical and/or commercial facilities Lead identification and implementation of new technologies and procedures from Development into Manufacturing Lead efforts focusing on alignment and harmonization of manufacturing process across multiple sites Leverage and maintain strong relationships with external partners Identify, design and manage small capital engineering projects Specific Knowledge, Skills, Abilities, etc: The candidate must have demonstrated verbal, written, and communication skills including ability to present complex information clearly and concisely, with a successful proven history of working with technical teams. Experience should include technical support of a cGMP manufacturing facility, including strong knowledge and engineering leadership for viral vector manufacturing and processing equipment, manufacturing support and technology transfer. Hands-on experimentation work in the development and optimization of upstream (cell culture, transfection) and downstream (clarification, chromatography, tangential flow filtration) unit operations for viral vector production Proven track record of interacting with CMOs, both domestic and foreign Demonstrated leadership skills, and the ability to interact with and lead diverse groups and teams are essential. Proven project management skills (organization, collaboration, multi-tasking, and communication), attention to detail, and the ability to perform well in a team based environment are required Prior experience in leading cGMP investigations utilizing formal Root Cause Analysis tools strongly preferred Prior experience in/knowledge of cell culture, viral vector manufacturing, recovery and/or purification of viral vector product in a manufacturing environment required Prior experience with SOPs, cGMPs and the know how to work within a regulatory environment required Prior experience facilitating/participating in Risk Assessments preferred Education/Experience/ Licenses/Certifications: Degree in Biology, Chemistry, Biochemical or Chemical Engineering, or equivalent area of related experience in biologics upstream manufacturing: Minimum of at least a with 10+ years or a degree with 8+ years or Ph.D. degree with 6+ of experience Preference given to candidates with experience writing regulatory submissions and participating in interactions with health authorities Knowledge of cellular immunology a plus Experience with cGMP, ICH guidelines, PPQ (process validation), control strategy development, and working within a Quality organization Proficiency utilizing MS Office products and working knowledge of statistical software (R, JMP, Minitab) Experience working in a self-driven, performance/results oriented, fast paced matrix environment Experience with disposable technologies such as SUBs and SUMs Experience managing CMO relations, including creation of statements of work, master service agreements, budgeting and timeline management 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. 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.