Summit, NJ, United States
Jan 13, 2023
Bristol Myers Squibb
Director - Manufacturing Sciences and Commercialization
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
Director – Manufacturing Sciences and Commercialization
Summit, NJ, Devens, MA or WA
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.
The Director - Manufacturing Sciences and Commercialization will lead a team of talented individuals and lead cross functional global team to enable process and analytical clinical and/or commercial transfers, support and implement lifecycle changes, comparability, and support the start-up of new internal facilities. He/she will participate in strategic discussions, anticipate bottlenecks, and transfer/ comparability risks, and address issues proactively, while fostering an environment of teamwork.
This person will be responsible for leading cross-departmental teams, planning risk assessments and strategy development for cell therapy comparability and technology transfer. This person will collaborate with SMEs, user groups, quality groups, and other stakeholders to accomplish transfer and start-up goals including support facility design, provide user specification, process simulations, transfer lot generation, comparability studies, test plan generation, operator training, and troubleshooting. The person will review and provide guidance on strategy in technical protocols and results in technical reports. This person will collaborate across all CMC functional areas to ensure project advancement, rapid and best in class execution, and communication of challenges/opportunities. He or she will play a key role in product lifecycle management, including development, characterization, commercialization, and evolution of cell therapy products
Interface with manufacturing site operations teams and process/analytical SMEs to learn and implement processes, procedures, and analytics by applying in-depth CAR-T manufacturing process knowledge
Promote innovative and efficient approaches to comparability incorporating risk-based elements and considerations unique to cell therapy production
Coordinate project planning, timeline, communications, and risk management activities
Support manufacturing, QC and QA throughout transfer by providing training, answering questions, clarifying intent of procedures, solving problems, and contributing to operational strategies
Anticipate and address issues in manufacturing related to process, documentation, or training
Provide technical input and investigation support for deviations/OOS
Assist in the management of changes, and in the implementation of process improvements
Provide technical input in support of regulatory submissions
Interact with other CMC teams including Operations, QA, Development, and Regulatory
Foster strong inter-team relationships to achieve common project goals
Evaluate and assist in statistical design and execution of comparability exercises for cell therapy products
Review regulatory filings summarizing the technology transfer and comparability strategy and results
Contribute to alignment and harmonization of strategies across multiple sites and stakeholders
Qualifications & Experience
Degree in Biology, Chemistry, Biochemical or Chemical Engineering, or equivalent area of related experience in biologics upstream manufacturing: Master’s degree with 14 years or Ph.D. degree with 12 of experience.
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 strong knowledge and technical leadership and proven track record of managing comparability/similarity projects.
Established track record of success with technology transfers and change management in commercial establishment.
Extensive knowledge of regulations, current industry practices, and experience with interpretation and application of guidelines and regulations.
Experience in development and/or characterization of biologics and/or cell therapy manufacturing processes
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 cross functional team-based environment are required.
Prior experience in/knowledge of cell culture, viral vector manufacturing, recovery and/or purification of viral vector product in a manufacturing environment required.
Strong experience with SOPs, change controls, cGMPs and the know how to work within a regulatory environment required.
Prior experience facilitating/participating in Risk Assessments required.
May require up to 25% of travel.
Position is primarily office based with occasional work in a classified GMP manufacturing environment.
Position is a team & project-based position that will require occasional shift work, weekends, and holidays.
The starting compensation for this job is a range from $173,000 –$217,000, plus incentive cash and stock opportunities (based on eligibility).
The starting pay takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation is decided based on demonstrated experience.
For more on benefits, please visit our BMS Careers site. Eligibility for specific benefits listed in our careers site may vary based on the job and location.
Why You Should Apply
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 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 ****. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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.
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.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to **** . Visit careers.bms.com/ (**** eeo-accessibility to access our complete Equal Employment Opportunity statement.
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.
2023-01-17 02:09:31.422 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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