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Director or Senior Director, Cell Therapy CMC Team Lead, Summit, New Jersey

CategoryMedical and Regulatory Affairs
Job typeFull-Time
CountryUnited States
StateNew Jersey

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


The CMC Team Lead is responsible for committed leadership of cross functional CMC development teams, establishing and leading comprehensive development strategies and tactics aligned with Development Product Team (DPT) objectives and incorporates all elements across vector, drug product, analytical, quality, regulatory, supply chain, manufacturing operations and clinical supplies. This position is accountable for proactive generation and implementation of strategic and tactical CMC development plans including acceleration, deceleration, risk/issue identification and mitigation, as well as project level sourcing recommendations.

The role requires strong communication and interpersonal skills with a strategic mindset while working with subject matter experts and stakeholders across multiple functions. This is a highly visible role with routine interactions with senior leadership and BMS wide governance bodies.

In addition to the aforementioned, the Sr. Dir. level candidate will be expected to demonstrate strong organizational leadership and acumen, drive appropriate portfolio linkages and serve the needs of multiple teams and sub teams. This also include responsibilities for leading strategic CTDO business initiatives and process improvement measures to improve alignment, performance and efficiencies. The candidate will be expected to demonstrate good people management skills, promote high leadership standards across BMS, and serve as a change ambassador.

Responsibilities will include, but are not limited to, the following:
  • Leading interdisciplinary matrix teams responsible for developing integrated CMC strategies that drive Development Product Team (GPT) objectives and incorporate all elements across vector, drug product, analytical, quality, regulatory, supply chain, manufacturing operations and clinical supplies.
  • Establish a CMC team roster by working with functional leaders to identify and on-board team members as needed.
  • Provide guidance and mentorship to the functional leads/subject matter experts within the CMC team.
  • Maximize alignment, cooperation, input, decision making, commitment and synergy of CMC team members to ensure their technical contributions meet/exceed program objectives.
  • Builds and motivates teams to become high performing
  • Ensures appropriate level of scientific and technical rigor, scale-up, and production strategies and timelines are in place to deliver successful clinical outcomes, meet clinical supply, and registration needs
  • Represents the CMC function at the global project team level and act as the single point of contact to present high level CMC plans and strategies.
  • Communicates effectively and transparently with functional representatives and stakeholders within CTDO, and other relevant stakeholders
  • Drives alignment, cooperation, input, decision making, commitment and synergy of team members to ensure their technical contributions, meet program objectives in delivery of project milestones through planning and execution of team goals
  • Presents at governance committees and effectively communicate program-related updates to ensure alignment on proposed strategies to senior management and stakeholders.
  • Provide committed and inspiring CMC leadership, stewardship, and advocacy, striving for process & manufacturing knowledge development, continuous improvement, acceleration, risk assessment and mitigation, resource allocation and support, as appropriate.
  • Collaborate with other CMC leads and team members to enable alignment of key project strategies and tactics, establish best practices on CMC development and project leadership, and continuous learning
  • Contribute to the management of overall PPLS portfolio, including supporting capability build efforts across PPLS and CTDO

Skills/Knowledge desired (active coaching will be provided to grow skills as needed over the course of the rotational assignment) :
  • +12 years of experience (14+ for Sr. Dir. level) in product development; previous experience interacting and working within a CMC team is preferred
  • Demonstrated ability for critical thinking and innovation; highly motivated, willingness to acquire new skills and ability to work under ambiguous environment
  • Ability to engage and align other stakeholders outside the project team, and work effectively with cross-functional stakeholders in a complex / changing /global environment
  • Excellent communication, writing, organization and presentation skills
  • Experience leading a group of individuals
  • Strong technical qualifications and skills in current functional role
  • Experience working in preparation of regulatory documents
  • Interpersonal and leadership skills to work with teams consisting of different functions and organizations
  • Ability to understand and communicate risks as well as developing and executing contingency plans for development programs
  • Ability to manage ambiguity, and make sound scientific and business decisions with limited information (when necessary) to advance development efforts in a dynamic environment
  • Ability to manage projects that have a potential combination of partnership/alliance or external efforts

Minimum of 12 years experience (14 years for Sr. Dir. level) in pharmaceutical development. Advanced degree (minimum of a M.S. with a Ph.D. preferred) in a technical discipline (e.g., chemistry, biochemistry, biology, pharmacy, chemical/biochemical engineering) that is relevant to pharmaceutical development and manufacturing of pharmaceutical drugs. Experience with Cell Therapy is highly desirable

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.


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.
EmployerBristol-Myers Squibb

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