Senior Manager, Project and Operations Management, External Cell Therapy Manufacturing

Celgene, NJ, United States
Sep 25, 2020
Required Education
Bachelors Degree
Position Type
Full time
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.

Title: Manager or Senior Manager- depending on level of experience;

Project & Operations Management, External Cell Therapy Manufacturing


This position will support projects in External Manufacturing Cell Therapy Development Operations. He/she will be responsible for the project and operational management of activities from the initial formation of the team through agency filings (e.g. BLA, MAA, JNDA), commercialization and clinical/commercial manufacturing at Contract Manufacturing Organizations (CMOs). He/she will work with functional leaders from Global Manufacturing, Science and Technology (GMSAT), Quality Assurance/Quality Control (QA/QC), Regulatory-Chemistry Manufacturing and Controls (CMC), Supply Chain, Clinical Scheduling and Patient Operations to develop a project plan/timeline, carry out the execution and provide operational support. Identify activities on critical path and risks, development of contingency plans, cross-functional team meeting management and communication.

We are looking for an individual with a breadth of professional experience to provide project management as well as operational support as needed. Ensure CMO operations that need BMS functional support are executed diligently. This role requires the ability to develop and maintain strong collaborative and cooperative working relationships with team members at CMO and across different functions and at different levels within the organization.

The roles and responsibilities include, but are not limited to, the following:
  • Manage independently multiple cross-functional external Manufacturing projects, with a focus on developing project overall plan and timelines, as well as providing operational support and supporting project execution.
  • Closely work with Virtual Plant Team (VPT) leads in all aspects, support operational activities, issue resolution, and provide support to establish and execute strategic plans.
  • Work closely with QA/QC team to support internal multiple sites and CMO Change Control and Deviation Management.
  • Support Patient Operations to resolve conflicts of clinical scheduling at CMO and further processing at Cell Therapy internal site network.
  • Effectively collaborate with functional leads, develop critical path analyses to identify potential ways to accelerate timelines, reduce costs or mitigate risks, arrange and manage team meetings and follow up on action items.
  • Work with finance and VPT/Strategic Sourcing lead to provide support in tracking budget, Purchase Orders and invoices.
  • Serves as a member of sub-teams to assure that functional deliverables are completed on time, on budget, and in line with project overall plan.
  • Proactively identify project risks and work with the team and team leader to develop contingency plans.
  • Works with the functional leaders, develop KPI, team goals and objectives, as well as team presentations for Governance Committee meetings.
  • Responsible for the preparation of monthly status reports, including those for the CTDO Leadership Team
  • Promote a culture of collaboration, cooperation, execution excellence, effective communication and cross-functional problem-solving to function as a high-performing team.

Key Competencies:
  • Broad knowledge of drug development, clinical and commercial manufacturing process in a GMP environment
  • Flexible to work with teams in different time zones across the globe
  • Experience with Biologics and or Cell Therapy is a plus
  • Strong analytical, problem-solving, and critical thinking skills
  • Demonstrated ability to earn the trust of team members and management
  • Must be able to interact and communicate effectively at all levels of the organization
  • Competent in Project Management tools and methodologies, e.g. MS Project, Visio
  • Excellent organizational and time management skills in a very fast pace and challenging and stimulating environment
  • Flexible and comfortable working with ambiguity as the program priorities change based on regulatory input, business, Research and Development (R&D) and clinical trial outcomes
  • Mindset for problem solving and focus on execution
  • Some global and local travel required

Education Requirements
  • Bachelor's degree in Life Sciences discipline
  • Advanced degree in Life Sciences and/or MBA a plus
  • Minimum 5 years of experience required

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.