Deviation Project Coordinator

DEVIATION PROJECT COORDINATORSUMMIT, NJOnsite/Remote- flexible but need local candidates only.Project Description: The Deviation Coordinator supports the manager of the investigations team, coordinating the assignment and delivery of deviations impacting the manufacturing, testing, and release of CAR-T products in the Summit manufacturing facility. This role will coordinate with cross-functional teams in a highly matrixed environment, and will be responsible for facilitating meetings, developing detailed project plans, driving decisions and commitments, and ensuring that issues are escalated to the manufacturing site's Leadership Team when required. Examples of this role include managing deviation assignment lists, reaching out to subject matter experts to support investigations, and developing project plans to drive process improvements. This role will work with other project management teams and subject matter experts from Manufacturing, Operational Excellence, Supply Chain, Manufacturing Science and Technology (MS&T), Quality Assurance, Quality Control, Process Development, Facilities Engineering, IT, EHS, Finance, and Regulatory.

• Lead cross functional project teams, to deliver the objectives of medium/high level complexity projects at the CAR-T Manufacturing site.
• Management and reporting of Key Performance Indicators (KPIs), including timelines, budgets, milestones, and escalations.
• Effectively manage team meetings, including the scheduling of meetings, the preparation of agendas, the development of meeting minutes, and the follow up on action items.
• Proactively identify, communicate, and escalate risks and decisions to site leadership.
• Work with team Subject Matter Experts (SMEs) to develop contingency plans when required.
• Responsible for the preparation of routine status reports and communicate project progress to stakeholders, supervisor, site leadership and senior executives.
• Promote a culture of collaboration, cooperation, execution excellence, effective communication, and cross-functional problem-solving to enable a high-performing team.
• Develop and manage continuous improvement projects in partnership with Operational Excellence SMEs.
• Lead VOC (voice of customer) and VOB (voice of business) surveys as needed.
• Lead implementation of CAPA projects related to deviation management.
• Collaborate with SMEs from the following (but not limited to) functions:
  • Manufacturing Operations
  • Operational Excellence
  • Supply Chain
  • Manufacturing Science and Technology (MS&T)
  • Quality Assurance
  • Quality Control
  • Process Development
  • Facilities Engineering
  • IT
  • EHS
  • Finance
  • Regulatory
• Be an active voice on the global and network program teams, adding experience and expertise while representing the interest of the manufacturing site by managing the expectation of external functions.
• Models the importance of GMP compliance and is a leader by example in this area.
• Build and maintain positive relationships with all functions at the S12 site, as well as with external customers and stakeholders.
• Performs other tasks as assigned.

• Bachelor's degree in engineering or a life sciences field. PMP certification preferred.
• 5+ years of relevant work experience required in pharmaceutical, biotechnology or related industries.
• Minimum 3 years of experience as a project manager and leader of cross functional teams.
• Demonstrates high degree of business acumen, with ability to deliver executive level presentations, challenge assumptions and drive decision making.
• Flexible and comfortable working with ambiguity.
• Strong understanding of current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA) and other regulatory requirements.
• Strong team leadership capabilities - including the ability to lead cross functional discussions and workshops with various levels within the organization, and drive alignment on critical decisions.
• Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique preferred.
• Basic knowledge of the regulatory drug product approval process. (NDA/BLA/MAA)
• Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external stakeholders.
• Excellent written and verbal communication skills.
• Ability to create clear and concise presentations, with the ability to deliver to audiences at all levels of the organization.
• Ability to travel < 10% of time.