Bristol Myers Squibb Company

Project Manager, Cell Processing External Manufacturing

Summit West, NJ, United States
Aug 28, 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.

The primary focus of the Project Manager, Cell Processing External Manufacturing role is to support programs and projects at current and future European cell processing Contract Manufacturing Organizations (CMOs). TheProject Manager, Cell Processing External Manufacturing will be a leader in the matrixed Virtual Plan Team (VPT) reporting to the Director, Cell Processing External Manufacturing. The Project Manager, Cell Processing External Manufacturing will be involved in project management, cGMP Manufacturing, Tech Transfer, scheduling, capacity management, generating and reviewing documentation, continuous improvement and governance of the European CMO.

The Project Manager, Cell Processing External Manufacturing may be responsible for projects from the initial formation of a Virtual Plant Team (VPT) through agency filing and commercialization of the product along with clinical and commercial manufacturing at CMOs. The Project Manager, Cell Processing External Manufacturing will work with functional leaders from Manufacturing Sciences, Quality Assurance, Quality Control, Regulatory, Supply Chain, Patient Scheduling and Patient Operations to develop and execute project plans and provide operational support. The Project Manager, Cell Processing External Manufacturing will identify critical path activities and risks, develop contingency plans, lead cross-functional team meetings and provide communication.

We are looking for a project manager with the breadth of professional experience to provide project management as well as operational support where needed. This role requires the ability to develop and maintain strong collaborative and cooperative working relationships with team members at third parties and across different functions and at different levels within the organization. The Project Manager, Cell Processing External Manufacturing is an effective communicator with a high degree of emotional intelligence needed to resolve difficult negotiations and issues with the CMO.

Key Responsibilities include but are not limited to the following:
  • Manage a portfolio of multiple cross-functional External Manufacturing projects, with a focus on developing and maintaining overall project plan and timelines.
  • Oversee CMOs assuring projects are delivered on time and meet or exceed expectations.
  • Effectively communicate status and expectations internally and to CMO.
  • Provide technical, quality and regulatory guidance to CMOs, leveraging internal SMEs.
  • Work closely with CMO and internal stakeholders to initiate deviations, complete investigations and initiate and implement change controls.
  • Facilitate process improvement initiatives with CMO and VPT.
  • Track and ensure internal/external audit observation deadlines or other regulatory commitments are met on-time.
  • Lead change management, issue resolution and adherence to agreed deliverables.
  • Collaborate with CMO to understand planned changes and drive, review and prioritize changes with the VPT.
  • Build and maintain strategic relationships withCMOs as well as manage relationships with key internal stakeholders.
  • Oversee CMO execution and performance, regularly monitor, gather and maintain and report KPIs.
  • Create process maps and tools for external manufacturing business processes.
  • Create procedures and review protocols and documentation.
  • Maintain the VPT SharePoint Center of Excellence Website.
  • Support root cause analysis and risk assessments.
  • Maintain action trackers, SharePoint Forms and Risk Registers.
  • Participate in regular staff and governance meetings to agree priorities and tactics.
  • Manage budget, initiate Project and Change Orders, track invoices and forecast CMO spend.
  • Maintain list of unbudgeted and extraordinary charges for regular resolution with CMO.
  • Perform Oracle Transactions for Commercial Manufacturing and maintain Master data, as necessary.

Skills/Knowledge Required
  • Bachelor's degree in Life Sciences or Engineering preferred.
  • 7+ years of experience working in cell therapy, biopharmaceutical manufacturing, supply chain, quality, biopharmaceutical drug development or project management.
  • Solid project management skills and experience managing complex projects.
  • PMI certification or Lean Six Sigma Black belt preferred.
  • Ability to influence senior management both internally and externally.
  • Ability to communicate clearly and concisely.
  • Ability to collaborate and build relationships.
  • Prior experience working with CMOs in various global regions.
  • Flexible to work with teams in different time zones, global and local travel 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.