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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, External Manufacturing Tech Transfer

Location: Seattle, WA or 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.

Come, join the BMS Cell Therapy Technical Operations (CTTO) Division, and be a part of the team building leading cell therapy platforms to serve our patients with novel cellular immunotherapies. CTTO plays a critical role in technology transfers, process validation, CMC life cycle management, technical oversight of external manufacturing partners, process engineering and establishing manufacturing standards to enable a robust and scalable global cell therapy manufacturing network.

We are looking for an Associate Director, Tech Transfer to join our Process Engineering team in External Manufacturing CTTO for production of personalized cell therapy products at Contract Manufacturing Organizations (CMOs) for both global clinical trials and commercial supply in collaboration with the Global External Manufacturing Group.

The successful candidate will support process and analytical clinical and/or commercial transfers, support and implement lifecycle changes, and support the training and start-up of new external facilities in collaboration with the Global External Manufacturing Group. The 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. He/she will also participate in strategic discussions, anticipate bottlenecks, and transfer risks, and address risks/issues proactively, while fostering an environment of teamwork.

Cross-functional collaboration with subject matter experts (SMEs) from the External Manufacturing, Development Group, Manufacturing Group, Supply Chain Group, and Quality group is essential to ensuring technical support is delivered to a rapidly growing CAR-T manufacturing organization.

Key Responsibilities:

• Function as technology and process SME

• Interface with external manufacturing team, manufacturing site operations teams and process/analytical SMEs to learn and implement processes, procedures, and analytics

• Support facility start-up efforts through specification, review, and testing of equipment and electronic systems

• Design and execute test plans, front runs, and other risk mitigation and validation exercises

• 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 process-related input to clinical or commercial supply facilities

• 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

• Manage multiple clinical and commercial products

Qualifications & Experience:

• Degree in Biology, Chemistry, Biochemical or Chemical Engineering, or equivalent area of related experience in biologics upstream manufacturing: Minimum of a Bachelor’s with 14+ years or a Master’s degree with 12+ years or Ph.D. degree with 10+ of experience

• Strong understanding of bioprocess unit operations, especially cell culture

• Extensive knowledge of regulations, current industry practices, and experience with interpretation and application of guidelines and regulations

• A strong mindset for high-quality, meticulous, and consistent execution of manufacturing processes and/or analytics

• Excellent written and verbal communication skills. Ability to convey complex technical issues to diverse audiences including internal teams, external partners, and health authorities.

• Strong interpersonal skills to work across multiple stakeholders and customers

• Established track record of success with technology transfers

• Familiarity with literature on cell therapy

• Ability to assess risk and develop contingency plans for process risks

• Experience working in a self-driven, performance/results oriented, fast paced matrix environment

• Ability to manage direct reports in a collaborative manner

• 2 years minimum of direct management experience

• Ability to expresses oneself clearly and concisely, by adjusting style, language and/or Flexibility to work shift hours may occasionally be required to cover critical process steps

• Ability to frequently travel, mainly to the CMO(s) under responsibility, is required terminology as appropriate for the audience

Preferred Qualifications:

• 3-4 years of experience in cell therapy technical operations

• 3-4 years of direct management experience

The starting compensation for this job is a range from $ $156,000 - $195,000 (if based in Summit, NJ) and $ $166,000 - $208,000 (if based in Seattle, WA), plus incentive cash and stock opportunities (based on eligibility).

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.

Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS

Career Site.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

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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/ (https://careers.bms.com/eeo-accessibility) 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.

Company: Bristol-Myers Squibb

Req Number: R1582233

Updated: 2024-06-18 03:29:17.555 UTC

Location: Seattle-WA

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.