Director, Cell Therapy Analytical Development

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.

Cell Therapy is one of the most groundbreaking new forms of cancer treatments 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.

Cell Therapy Analytical Development is seeking a Director to lead the Potency & Functional Characterization organization, which reports to the head of Cell Therapy Analytical Development, Seattle. The successful candidate will lead several groups and individuals who are collectively responsible for QC potency and functional characterization methods for autologous and allogenic cell therapies, including clinical and commercial CAR T cell products.

The Director of Potency & Functional Characterization will lead an organization responsible for selecting technology platforms, developing analytical methods, and managing their lifecycle. These methods will be used to further the understanding of cell therapies, support development of the manufacturing processes, and/or QC release of the drug product. The Director of Potency & Functional Characterization will have demonstrated experience in both clinical and commercial programs, be familiar with industry best practices, and have expertise in regulatory expectations and phase-appropriate strategies. In addition, the successful candidate will have hands-on experience in assay development and transfer, have extensive project and team leadership experience, and will be interested in driving projects requiring close collaboration with other groups, such as discovery research, product sciences, process development, and QC. The Director of Potency & Functional Characterization will be passionate about developing novel medicines, thrive in an intellectually challenging environment, and enjoy collaborating with a team of like-minded thought- and people-leaders.

Responsibilities and REQUIRED COMPETENCIES

• Lead teams that are responsible for conducting technology assessments, developing analytical methods, lifecycle managing methods, and drafting regulatory responses and fillings.
• Define the potency and functional characterization strategy in accordance with including industry best-practices, phase-appropriate strategies, and regulatory expectations.
• Manage the portfolio of existing methods, lifecycle management activities, development of new capabilities, and identification of novel opportunities.
• Strongly advocate for the professional development of the team, including but not limited to championing industry-best practices, identifying internal and external learning opportunities, promoting conference attendance, and establishing effective mentoring.
• Provide regular communications on progress towards objectives, escalate issues and risks, and recommend risk-mitigation strategies to Cell Therapy Analytical Development leadership and other relevant stakeholders, including the Analytical Strategy Team, Clinical QC, Analytical Operations, Global Product Quality, and Product Sciences.
• Maintain awareness of the competitive landscape in cell and gene therapy manufacturing and analytical technologies.
• Can-do attitude and ability to work in a highly-matrixed and dynamic business environment, including ability to interact and communicate to senior level executives.
• Deep scientific curiosity and commitment to advancing therapeutic innovation that provides better options for patients.
• Strong problem-solving and risk-based decision-making skills and a strong ability to influence or manage without direct authority.
• Highly developed interpersonal, communication and negotiation skills.
• Strong management skills and clear ability to influence and effectively align, motivate and empower teams to progress project goals in a cross-functional matrix environment.

EDUCATION AND EXPERIENCE:

• Ph.D. in relevant scientific discipline e.g. immunology, cell biology, biochemistry or molecular biology with 15+ years of experience in analytical development, QC and method lifecycle management in biotech or pharmaceutical industry
• Experience establishing and running analytical development teams.
• Proven record in the successful leadership of analytical and/or CMC development teams.
• Demonstrated experience in preparing and executing complex strategic plans and balancing competing priorities.
• Demonstrated experience in the use of strategic planning to advance technological objectives.
• Well-versed in a wide array of analytical techniques such as Flow cytometry, ELISA, qPCR, ddPCR, NGS, spectroscopy, cell counting, and other applicable methods
• Experience with development and qualification of cell-based assays for QC release testing and product characterization is required
• Strong knowledge and statistical skills for interpretation of potency data in context of broader process and product development.
• Strong background in analytical development, as well as a knowledge of cGMPs, ICH, and relevant regulatory guidelines and experience in writing relevant regulatory submissions
• Deep working knowledge of regulatory guidance and quality standards, with experience authoring and reviewing regulatory submissions and responses (biologics license application submission) and interacting with Health Authorities.
• External scientific engagement that may include a combination of publications, industry white paper contributions, presentations at scientific meetings, membership on (or leading) cross-company working groups or consortia.
• Ability to excel in a team-based environment, partnering and influencing in a professional and positive manner.
• Excellent verbal and written communications skills.

WORK CONDITIONS:

The job may be based in Seattle, WA with up to 10% travel to internal and external partner organization locations.

If you want to challenge yourself, accelerate your career, and give new hope to patients, there’s 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.

BMSCART

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and 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.

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 approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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