Early Stage CMC Lead

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Job Information

Bristol Myers Squibb

Early Stage CMC Lead

in

Seattle

Washington

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.

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.

The Early Stage CMC Lead is accountable for leading CMC development of viral vector activities supporting global regulatory filing and approval for early stage cell-therapy products, including CARs and TCRs. This is a matrix leadership role that collaborates across multiple functions to arrive at a comprehensive Vector CMC development plan. The early stage CMC lead supports early stage product development by integrating vector development activities within the overall cellular therapy product development plan. This is a highly visible and influential role in the organization that will interact extensively with business partners, senior leadership across BMS, and external collaborators. To be successful in this role, the ideal candidate must have, extensive product 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:

Lead a viral vector CMC matrix team to deliver early-stage viral vector CMC development plans for cell therapy products within BMS's portfolio

Lead all CMC activities, including process characterization and tech transfer for pivotal production, required for successful, on-time global regulatory filings

Define viral vector CMC goals, milestones, and timelines for the team, coordinate and monitor progress, and manage team activities to ensure successful implementation of the endorsed development plan

Represent the viral vector CMC team in CMC technical and program reviews with governance boards and senior management

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.

Participate in regulatory strategy development, regulatory filings, and meetings with regulatory agencies.

Basic Qualifications:

B.A./B.S. with ≥10 years of experience or Ph.D. with 4 years of experience in biotechnology or cell and gene therapy with exposure to all stages of product development

Experience on CMC teams including authoring and reviewing relevant regulatory submissions

Highly developed interpersonal, communication and negotiation skills, including the ability to clearly articulate complex options to senior decision makers.

Experience collaborating with external manufacturing organizations; understanding risks and typical pitfalls of external manufacturing

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 CMC team towards its 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 thinking

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 the resources to pursue their goals, both at work and in their personal lives.

Company:

Bristol-Myers Squibb

Req Number:

R1526303_EN

Updated:

2020-06-10 00:00:00.000 UTC

Location:

Seattle,Washington

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.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com