Executive Director, Drug Product Process Development- Cell Therapy

Company: Disability Solutions
Location: Seattle
Posted on: November 3, 2024

Job Description:

Working with UsChallenging. 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: .Summary:The Executive Director, Drug Product Process Development is accountable for global network of cell therapy DP process development. This role is responsible for driving innovation and implementing end to end practices for leading cell therapy drug product processes and integrating with the global CT operations network strategy. Accountable for holistic cell therapy DP process development strategy to ensure enterprise level considerations are applied across the portfolio of CT assets including all autologous, allogeneic and iPSC/NK based approaches, influencing overall CT development strategy. Role & Responsibilities:

• Lead all cell therapy DP process development activities and teams across multiple sites
• Partner and collaborate with Accept, Gene Delivery Process & Analytics Process Development, CT DP Analytics, and GMSAT, and leverage expertise in the broader BMS development functions as required
• Develop and implement cost effective and cost competitive processes for all cell therapy approaches
• Develop phase appropriate FIH processes to enable speed on portfolio delivery
• Define and harmonize global strategies for developing, characterizing and enabling validation of CT drug product processes for both early and late-stage assets as applicable
• Develop and lead global strategy and implementation of DP process strategy aligned with the internal operations network, the R&ED strategy and commercial considerations for CT
• Provide technical oversight of CT process related investigations at internal and external manufacturing sites as required.
• Lead enterprise assessment of novel technologies including automation, expression platforms, and associated IP helping to protect and create value for the BMS portfolio of clinical cell therapy assets
• Responsible for developing and implementation of PAT as it relates to CT DP processes in the network, in partnership with BD
• Partner with GMSAT on automation and LCM for Abecma and Breyanzi including leadership of Breyanzi single train process development
• Build high performing teams that excel at working in matrices across BMS. Attract, hire, manage and develop world class scientific, technical and engineering talents and create an environment where they can thrive.
• Create strong partnerships to continually evaluate and evolve the department's strategic plan to ensure alignment with business objectives while balancing cost, time and speed.
• Drive engagement with the broader external cell therapy community and influence direction of the field
• Serve as a member of the Cell Therapy Development leadership team, participating in portfolio review and project governance meetings and providing guidance for best practices and direction for continuous improvement.
• Contribute to, review and approve regulatory CMC submissions to ensure their quality and technical contentRequirements:
  • PhD preferred in biochemistry, biochemical engineering, or other related field
  • Minimum 15 years of experience, leading teams of people (leading leaders) across multiple geographic locations (-25 % travel required)
  • Demonstrated experience in developing and establishing process strategies required for early, late, and commercial stage biological/ cell therapy processes
  • Experience with integration of process control strategies with understanding of attribute sciences
  • Broad understanding of metabolomics and CT characteristics as it relates to production technology
  • Experience with multiple analytical techniques used to characterize and quantify CT approaches
  • Experience with process characterization of large molecule processes
  • Ability to work across all cell therapy approaches (autologous, allogeneic, gene-edited, iPSCs etc)
  • Experience partnering with CMC teams to define and deliver tech strategy required for product licensure.
  • Understanding of ICH guidelines
  • Experience with partnering externally on product development
  • Understanding of enterprise network strategy and development execution impact on P&LThe starting compensation for this job is a range from $245,000 USD - $325,000 USD, 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.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 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 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 . 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: Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Keywords: Disability Solutions, Everett , Executive Director, Drug Product Process Development- Cell Therapy, Executive , Seattle, Washington