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Bristol Myers Squibb

Associate Director, Breyanzi Product Champion, Cell Therapy Technical Operation, Commercial DP at Bristol Myers Squibb

Bristol Myers Squibb Madison, OH

Job Description

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. 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: SummaryThe Associate Director Breyanzi Product Champion leads the technical agenda for Breyanzi commercial cell therapy partnership with matrix technical teams and multifunctional stakeholders this role drives the strategic technology roadmap for Breyanzi manufacturing and lifecycle management. The position is accountable for the development optimization and continuous improvement of manufacturing operations technology transfer and process robustness for Breyanzi.The role will report to the Senior Director CTTO and interface with Drug Product Development Operations Quality Regulatory MS&T and other colleagues globally.Key ResponsibilitiesOwn the Drug Product (DP) Technical Roadmap for Breyanzi ensuring alignment with franchise strategy commercial objectives and technical innovation.Serve as technical lead for post-market process changes technology transfers and process optimization initiatives across internal and external manufacturing sites.Coordinate technology transfer (TT) validation and regulatory submission strategies in collaboration with Lifecycle Management (LCM) and cross-functional partners.Act as technical subject matter expert for Breyanzi providing expertise and leadership on product and process matters.Lead weekly strategy and execution meetings by setting agendas driving discussions coordinating operational progress and troubleshooting and ensuring follow-up on action items across cross-functional teams.Attend and actively participate in meetings with TPT (and Go Team as needed) to ensure effective communication and alignment on technical and strategic objectives.Ensure representation from all manufacturing sites External Manufacturing (ExM) and laboratory teams in relevant meetings and decision-making processes.Collaborate with clinical and manufacturing sites to develop and implement innovative technologies that enhance product quality robustness and cost efficiency.Provide technical justification and direction for change controls investigations and regulatory submissions.Author and review technical documentation for regulatory filings product quality reviews and governance presentations.Manage global change controls CAPAs and proactive compliance initiatives.Represent Breyanzi product teams in regulatory interactions inspections and internal/external forums including committees and industry groups on development technology transfer manufacturing specifications process validations and launch.Identify product cost drivers and realizes opportunities for cost reduction early in product/process development or as part of post-filing improvements.Assist the manufacturing sites globally to resolve significant quality events that require in-depth technical expertiseMentor junior team members and foster a culture of accountability inclusion and innovation.Promote diversity equity and inclusion in team dynamics and project execution.Qualifications & ExperienceBachelors degree in Engineering Life Sciences Biology Chemistry Biochemical/Chemical Engineering or related field.Advanced degree (M.S./Ph.D.) preferred; equivalent experience considered.Minimum of12 yearsof relevant experience in cell therapy biologics or pharmaceutical manufacturing.Proven experience leading technical projects in a matrixed environment.Strong knowledge of cGMP operations process validation regulatory compliance and change management.Experience with Cell Therapy Drug Product Manufacturing and sterile drug product operations.Excellent communication strategic thinking and problem-solving skills.Experience with project management tools and Lean Six Sigma methodologies is a plus.Ability to travel up to 20%.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.Compensation Overview:Devens - MA - US: $185360 - $224612
Madison - Giralda - NJ - US: $173230 - $209914
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. 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 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 Years 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.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 a supportive culture promoting global participation 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 ProtocolBMS has an 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 . Visit 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: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.Required Experience:Director Key Skills Program assessment,FDA Regulations,Manufacturing & Controls,Program Evaluation,budget forecast,Research Experience,Operations Management,Research & Development,Strategic Planning,Contract Management,Leadership Experience,negotiation Employment Type : Full-Time Experience: years Vacancy: 1

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