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 .
Cell Therapy is one of the most groundbreaking new forms of cancer treatment 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 hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration, and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
Position Summary: We are seeking an enthusiastic, self-driven individual to join the Gene Delivery & Editing Process Development team. Our team develops the end-to-end processes and technologies to deliver the critical raw materials used in the manufacturing of engineered T cells, including viral vectors. This team member will play a key role in the tech transfer and support of clinical manufacturing (up to process performance qualification (PPQ)) of gene-delivery raw materials such as: DNA, RNA, Enzymes, RNPs, viral vectors, and cell lines. The ideal candidate will have experience with process development and/or early-stage clinical manufacturing including proficiency in supporting tech transfers, deviations, change controls, and OOS investigations. Hands on experience operating production processes in a manufacturing environment is desirable.
Key Responsibilities:
- Lead process and technology transfers, change management, and technical process support for successful clinical stage manufacturing of gene-delivery raw materials such as: DNA, RNA, Enzymes, RNPs, viral vectors and cell lines.
- Monitor internal and external clinical manufacturing up to process performance qualification (PPQ), identifying and managing implementation of process improvements and change controls, managing process deviations and out of specification investigations through approved quality systems for manufacturing of gene-delivery raw materials
- Visit internal and external manufacturing sites as needed to support OOS investigations, tech transfer activities, and regulatory inspections
- Develop, implement, and optimize early-stage tech transfer plan to streamline transition from PD to clinical manufacturing teams
- Identify technical gaps in the form of risk assessments and work with PD colleagues to de-risk tech transfer, scale up/scale down and improve clinical vector processes throughout the clinical development period
- Conduct due diligence to assess onboarding of new gene-delivery vendors
- Author manufacturing and process development sections of regulatory filings as well as technical documents suitable for presentation to regulatory authorities
- Up to 25% travel
Education & Experience:
- PhD. (entry level), M.S. with 3+ years of experience or B.S. with 5+ years of experience in process development or commercial manufacturing
- Experience in a biotechnology process development or manufacturing environment for globally regulated products, such as cell & gene therapies, vaccines, or biologics
- Experience with PD and/or early-stage clinical manufacturing with experience in managing process development, tech transfers, Deviations and OOS investigations.
- Experience writing and reviewing GMP documentation
- Experience using statistical software (ex. JMP) for analysis of process and manufacturing data
- Experience with cGMP and ICH guidelines
- Proven ability to work in a fast-paced, multi-product, matrixed environment spanning groups at different geographical locations
- Ability to communicate clearly and concisely through oral presentation and technical writing, including development reports and regulatory filings
- Demonstrated ability to effectively work in cross-functional teams, meet deadlines, and prioritize multiple projects
- Desire and drive to increase access of cell and gene therapy products and passion for their impact on the lives of patients with serious diseases
If you want to challenge yourself, accelerate your career, and give new hope to patients, there is 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.
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.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
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