Bristol - Myers Squibb Company

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 Associate Director, Technical Product Lead (CTTO) , will be responsible for technical oversight of Cell Therapy products including ownership of process control strategy, and life cycle management activities for commercial products and post-commercial support and implementing process improvements for cell therapy processes.. Strong understanding of bioprocess unit operations, especially cell culture.

associate director

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 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. Read more: careers.bms.com/working-with-us. Title: Associate Director, Technical Product Lead, Cell Therapy Technical Operations (CTTO) Location: Summit, NJ 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 Associate Director, Technical Product Lead (CTTO), will be responsible for technical oversight of Cell Therapy products including ownership of process control strategy, and life cycle management activities for commercial products and post-commercial support and implementing process improvements for cell therapy processes. Key Responsibilities: <ul><li>Own and maintain the process control strategy.</li><li>Maintain oversight of process capability through data trending and statistical analysis of critical variables, ensure processes are robust, in a continued state of validation, and continuously improving.</li><li>Serve as the single point of technical governance to the Technical Product Team (TPT) to manage all technical aspects of product lifecycle management.</li><li>Develop product technical strategies including manufacturing requirements, process improvement plans, post approval life cycle management plans and ensure successful and timely execution working across functional groups.</li><li>Provide technical leadership on strategic initiatives including tech transfers, process validation, technical reports, data analysis, process monitoring, change control, product comparability and second line support of technical/scientific process issues.</li><li>Collaborate with Technical Development groups on lifecycle improvements.</li><li>Provide technical content for significant documents such as PPQ or comparability assessments, author content for regulatory submissions, present technical strategies during major health authority interactions and inspections.</li><li>Perform and support data monitoring of manufacturing processes to understand process capability and to increase robustness and sustainability.</li><li>Present complex technical topics internally and externally.</li><li>Provide scientific leadership on technical teams for life cycle management changes and process improvements.</li><li>Leadership/mentorship for direct reports to support business goals and career development, as required</li><li>Collaborate with Manufacturing, site MSAT, PS&T, other functions, and technical development groups to achieve GMP process solutions.</li><li>Provide technical content and author regulatory submissions and responses to information requests by regulatory agencies.</li><li>Provide technical guidance to support launches of new markets and products</li></ul> Qualifications & Experience: <ul><li>Degree in Biology, Chemistry, Biochemical or Chemical Engineering, or equivalent area of related experience in biologics upstream manufacturing: Minimum of a Bachelor's with 12+ years or a Master's degree with 10+ years or Ph.D. degree with 8+ of experience</li><li>2+ years experience managing direct reports and/or matrix teams</li><li>Strong understanding of bioprocess unit operations, especially cell culture.</li><li>Extensive knowledge of regulations, current industry practices, and experience with interpretation and application of guidelines and regulations</li><li>A strong mindset for high-quality, meticulous, and consistent execution of manufacturing processes and/or analytics</li><li>Excellent written and verbal communication skills. Ability to convey complex technical issues to diverse audiences including internal teams, external partners, and health authorities.</li><li>Strong interpersonal skills to work across multiple stakeholders and customers</li><li>Sound experience of data handling and applied statistics</li><li>2-3 years of experience in cell therapy technical operations, preferred</li><li>Experience with commercial product support, i.e. post-marketing commitments, life-cycle changes, comparability, preferred</li></ul> #LI-Hybrid VETERAN BMSCART If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as "Transforming patients' lives through science™ ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS 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: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. 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. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

START NEW SEARCH