Director Cell Therapy CMC Lead

Profile

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.

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Summary:

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.

Responsibilities will include, but are not limited to, the following:


Lead an interdisciplinary, matrix team 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
Represent 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


PREREQUISITES

Minimum of 12 years experience 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

Skills/Knowledge desired :


12 years of experience 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


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.

Company: Bristol-Myers Squibb

Req Number: R1527886_EN

Updated: 2020-07-20 00:00:00.000 UTC

Location: Summit,New Jersey

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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