Director/Senior Director, Gene Delivery Process and Analytical Development

Company: Bristol-Myers Squibb
Location: Seattle
Posted on: January 26, 2023

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: 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.The Director/Senior Director will be accountable of leading the gene delivery analytical development group within the Gene Delivery Process and Analytical Development (GDPAD) organization supporting clinical and commercial cellular products. This group develops release and characterization methods for our gene delivery materials, which include lentiviral vectors (LVV), adeno-associated viral vectors (AAV) and non-viral based gene delivery materials. In addition to method development and qualification, the group supports method transfers to Quality Control labs and is responsible for the determination of our critical quality attributes (CQAs) for gene delivery materials.. This analytical organization is accountable for operations involving the execution of the viral vector determination testing procedure for disposition of a commercial lentiviral vector. In this capacity the Director/Senior Director will oversee a large team with responsibility for GMP testing to support product release and stability, non-GMP testing to support process development, and various life cycle management initiatives, including a lab capacity expansion project that is required to support the increased commercial demand of the product. The Director/Senior Director will also be part of the GDPAD leadership team and play a critical role in establishing our high-level strategies and platforms for viral vector and gene editing raw material processes and analytical methods. This is a highly visible and influential role in the organization that will interact extensively with partner organizations, senior leadership across BMS, and external collaborators. To be successful in this role, the ideal candidate must have extensive analytical development expertise in biotechnology or cell and gene therapy areas, regulatory and compliance awareness, strategic thinking, strong business acumen, excellent leadership and influencing skills.Responsibilities:

• Supervise technical leaders and people managers of the Vector Release Methods group; hire, mentor and develop exceptional team members; cultivate diverse and complimentary analytical skill sets within the group
• Oversee GMP testing operations for vector volume determination test for a commercial lentiviral vector
• Support method development, qualification and transfer to Quality Control labs
• Provide technical leadership on gene delivery analytical topics within group
• Ownership of overall gene delivery analytical platform
• Represent gene delivery analytical development cross-functionally to members of Process Development, Global Product Quality, and Cellular Process and Analytical Development
• Communicate and coordinate with the Gene Delivery Analytical Strategy team to support program deliverables
• Represent gene delivery analytics at various BMS governance forums
• Ensure appropriate technical representation from program activities including author sections of regulatory submissions and requests for information, technical investigations, and business development opportunities
• Accountable for documentation practices within the team including analytical target profiles, method qualification/technical/method bridging reports, and VVDT quality systems work product
• Provide regular communications to the team, sub-teams, functional lines, stakeholders, and management. Escalate issues and risks and recommend risk mitigation strategies according to governance procedures.
• Stay abreast of evolving global regulations and industry practices for the development and approval of Cell Therapy products worldwide.
• Create a high functioning team, holding team members accountable for performance, and mentoring/coaching as needed. Provide input into the performance reviews of team members.Basic Qualifications:
  • B.A./B.S. with --- 18 years of experience or Ph.D. with --- 10 years of experience in biotechnology or cell and gene therapy with exposure to all stages of product development
  • Broad experience in analytical development including method development, qualification and reviewing relevant regulatory submissions; knowledge of molecular, biochemical (ELISA), and high-complexity cell based analytical methods
  • Highly developed interpersonal, communication and negotiation skills, including the ability to clearly articulate complex options to senior decision makers.
  • Experience collaborating with external contract test labs; understanding risks and typical pitfalls of an external network
  • Demonstrated matrix management skills and clear ability to influence and effectively align, motivate and empower the team to progress project goals in a cross-functional matrix environment.
  • Proven ability to work effectively with cross-functional leaders in a complex/changing global environment.
  • Subject-matter expertise to strategically lead the gene delivery analytical and VVDT teams towards their goals
  • Demonstrated experience in preparing and executing complex strategic plans and balancing competing priorities.
  • Strong problem-solving and risk-based decision-making skills and a strong ability to influence or manage without direct authority.
  • Demonstrated ability for critical and strategic thinkingThe starting compensation for this job is a range from $182,000-$262,000 plus incentive cash and stock opportunities (based on eligibility).The starting pay takes into account characteristics of the job, such as required skills and where the job is performed.Final, individual compensation is decided based on demonstrated experience. For more on benefits, please visit our BMS Careers site.Eligibility for specific benefits listed in our careers site may vary based on the job and location.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.#LI-OnsiteBMSCARTIf 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 ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.COVID-19 InformationTo 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.BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation 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 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.

Keywords: Bristol-Myers Squibb, Seattle , Director/Senior Director, Gene Delivery Process and Analytical Development, Executive , Seattle, Washington