Director, Rapid Response Lead

4 weeks ago

Devens, United States Bristol-Myers Squibb Full time

**Working with Us**
Challenging. 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.

Recently, Cell Therapy Development and Operations has identified the need for a role leading the resolution of network wide critical issues impacting the supply and compliance of our Breyanzi and Abecma brands. The Rapid Response role is a critical matrix leadership position which will support the Vector Lead's in ensuring supply stabilization in the near-term and accelerate our future. The role will lead multiple, concurrent cross-functional response teams that require close collaboration with a wide set of site and network SMEs, technical, quality and business operational leaders, plus regular interface with CT LT+1 executives.

Working with multiple internal and external stakeholders, this role has the responsibility to lead the assessment of the current situation, put a team structure and meeting cadence in place to manage the issue in a timely and effective manner that minimizes supply & compliance impact. This is achieved by driving and tracking mitigation actions to ensure adherence to critical path, communicating response status and escalation to senior stakeholders. The role will pull together SMEs and stakeholders and ensure the construction of clear path forward to resolution. Key to this, with limited oversight, is the ability to understand the end-to-end view across the functions, keeping in mind compliance and impact to supply and hence the patient. The role will require use of lean problem solving / OE tools to prevent recurrence of issues.

Though part of the vector and external manufacturing operations team, this role also has a broad remit beyond contract manufacturing organizations (CMOs) and/or contract testing laboratories (CTLs). Specifically, where requested by CTDO leadership, to partner with the CTGM team to drive the resolution of similar supply issues.

**Key Responsibilities**
- Develop and own the cross-functional integrated response plans.
- Organize and lead cross functional team meetings, workshops and analyses to ensure actionable output and clear, balanced decision making.
- Prepare, co-ordinate and usually lead communications for peers, senior stakeholders / leadership
- Drive and track actions, develop and drive detailed plans, identify critical path and timing, hold team members accountable for due dates.
- Develop a strong relationship with supply chain and into commercial operations to understand supply impact and impact to patients.
- Facilitate problem solving and decision making to address risks and issues.
- Foster high performance teamwork and maintain strong relationships with operational and functional leadership.
- Utilize standard project management tools and processes for tracking and reporting.
- Build upon and develop the existing Rapid Response Team framework and approach, test approaches and capture best practices in a guide.
- Ensure establishment of strong, positive, engaged CTDO culture - including focus on safety, engagement, and patient mission focus.
- Identify and remove obstacles, create options and escalate as appropriate to drive response activity in line with key business milestones & budget.

**Internal/External Stakeholders and partners**
- Cell Therapy functions (CT Manufacturing Operations, Product Operations, Quality Assurance, Quality Control, CT Development, MSAT, Supply Chain, Finance, Regulatory, etc.)
- Cell Therapy Franchise
- Enterprise Level partners - Alliance Management, Business Development, IT

**Qualifications & Experience**
- B.S. or B.A. in science and/or engineering (biotechnology, biology, engineering, or related sciences). Master or advanced degree (sciences or business) and prior cell therapy development experience preferred.
- 8-10 years business experience, with 6-7 years in a BioPharma operational or development discipline, including demonstrated 3-5 years of experience managing projects and programs.
- Demonstrated leadership & collaboration working in, or closely with, Supply Chain, GMP Manufacturing Operations, Manufacturing Science & Technology, Project & Program management, Quality Assurance / Quality Control Operations and related functions.
- Broad technical expertise with biologics or cell therapy commercial manufacturing & analytical processes, technology transfer and/or start-up phase experience highly desired.
- The role requires demonstrated competencies & success associated with
- Analysis and simplificat

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