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Associate Director, Warren Site MSAT
3 months ago
Working with UsChallenging. Meaningful. Life-changing. Those arent 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. Youll 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, Clinical Site MSATLocation: Warren, NJPosition SummaryThe Associate Director Clinical Site CAR T Manufacturing, Science, and Technology leads a team responsible for supporting the production of allogeneic cell therapy products for global clinical trials. Oversees the process engineering, manufacturing support, new product introduction, technology transfer, and life cycle management of these programs. Supports tech transfer of critical raw materials such as vector and RNP fill/finish. Provides technical and continuous improvement support to the production operations to ensure rapid, flawless, compliant, and cost-effective delivery of quality products.Key ResponsibilitiesEnsure safe and compliant cGMP operations;Maintain permanent inspection readiness and actively support regulatory inspections.Interface with regulatory authorities as required to support Manufacturing Operations audits.Foster a culture of compliance and strong environmental, health, and safety performance.Oversee technical risk assessments.Support Director in developing productivity with the MSAT team;Implement metrics to track and manage completion of objectives and projects;Monitor the execution of technical projects and develop presentations to disseminate results to project stakeholders and senior management.Ensure employees have the resources needed to meet or exceed their goals; ensure adequate systems, procedures, personnel and equipment are in place.Stay current with industry trends and standards (e.g. PDA, ISPE) and participate in best practice forums consistent with function responsibilities.Build trust and effective relationships with peers and stakeholders.Create an environment of teamwork, open communication, and a sense of urgency.Support Clinical Production Activities;Continuously monitor, anticipate and permanently resolve issues that may arise during production.Interface with operators and serve as process SME. Learn the procedures, analytics and document any known sensitivity.Provide technical input and investigation support for production related investigations, ensuring compliance with internal standards and regulatory requirementsWork closely with Engineering /Maintenance on the design and implementation of new technology and new systems/facilities related to production process needsReview and revise the content of technical documentation (e.g. investigations, changes, SOPs and batch records)Lead gene editing and delivery tech transfer team from late stage development activities to pivotal transferQualifications & ExperienceBachelors Degree required in Engineering or related fieldMasters Degree preferred12 or more years of work experience in the biopharmaceutical or related industry5 or more years of people management experience10 or more years of manufacturing support or related experience in the biopharmaceutical industryAdvanced knowledge of cGMPs and biopharmaceutical/cell therapy regulationsAdvanced knowledge of facility/clean room design, process, equipment, automation, and validationIntermediate experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing processesWorking knowledge of Delta V/OSI PiAdvanced hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologiesStrong verbal/written communication skills and ability to influence at all levelsAdvanced ability to think strategically and to translate strategy into actionsKeen ability to prioritize and provide clear direction to team members in a highly dynamic environmentAdvanced knowledge in Quality by Design (QbD) approach in ManufacturingIntermediate knowledge in Quality Risk Management and risk assessment methodologiesIntermediate experience with Operational Excellence and Lean ManufacturingImplement metrics to track and manage completion of objectives and projects.If you come across a role that intrigues you but doesnt 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 Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. 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. #LI-OnsiteBMSCARTVETERANIf you come across a role that intrigues you but doesnt 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 CareersWith 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 ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.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.
