Manager, External Manufacturing

2 months ago

Philadelphia, United States Adaptimmune Full time
Job DescriptionJob Description

Adaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.

Our company culture is rooted in trust, inclusion, our capacity to collaborate, and our commitment to being honest and brave in our desire to successfully transform the lives of people with cancer.

Primary Responsibility

Manager, External Manufacturing will assist in both internal and external coordination of Contract Manufacturing Organizations (CMOs) managed under the External Manufacturing team. This includes but is not limited to leading a matrix team (Virtual Site Team)  to align on internal objectives and communicate the outputs to an externally facing forum specific to each CMO. Timelines, budget, and overall project goals will be managed via VST, with the Manager of External Manufacturing determining when escalation is appropriate.
Negotiation and understanding of key contract terms is expected related to the work being performed at each CMO.

Key Responsibilities

Virtual Site Team Management
  • Lead and coordinate cross-functionally all ongoing and upcoming production or tech transfer activities at each CMO inclusive of cell drug product, viral vector, and plasmids manufacturing.
  • Establish business processes and cross-functional relationships with internal/external partners, including senior leaders at the CMO.
  • Assist with coordination of governance meetings, inclusive of operational through C-level steering committee
  • Maintain accessible record of VST decisions, timelines, and goals to ensure stakeholders are informed and held accountable to functionally appropriate tasks.
  • Act as internal and external escalation point for CMO-related discussions.
Relationship Building / External Coordination (CMO)
  • Develop strong relationships with both internal VST stakeholders and external operational CMO representatives
Contract Negotiation/Support and Invoice Management
  • Support contract negotiations.
  • Ensuring that all contractual obligations with our CMOs are met
  • Manage invoice tracking and timely approvals.
Key Metrics Management and Development
  • Develop and monitor key KPIs specific to each CMO with a monthly summary/output of the performance.
  • Support coordination of business review series at CMOs to review metrics/KPIs/overall health of business
Logistics Coordination
  • Ensure sufficient supply of ADAP-supplied materials via logistics requests
  • Support coordination of CMO discussions to align on timing and process for upcoming shipments
Front Line Support
  • Provide front-line support for process or equipment related issues at the CMO and ensure cross-functional engagement internally.
  • Drive the resolution of major and critical deviation investigations.
  • Partner with Process Development and Quality to tech transfer and qualify/ validate manufacturing processes and QC methods.
  • Other duties as assigned.
other requirements
  • Minimum at-home requirement of High Speed Internet to ensure ability to work remotely from home as required by business needs.
  • Preferably bi-weekly in the office ( in sync with team meetings or other key meetings )
  • Quiet and private work area while working remotely
  • Valid driver’s license
  • Ability to travel, estimated to be 20% on average.
  • Attend business reviews, as needed
  • Visit/tour CMO manufacturing space

At Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.

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