Director Vector External Manufacturing

Celgene   •  

Seattle, WA

Industry: Pharmaceuticals & Biotech


11 - 15 years

Posted 34 days ago

This job is no longer available.

Job Summary

The primary focus of the Director, Vector External Manufacturing role is to matrix-manage the vector program 'virtual plant teams' (VPTs) from initial formation of a CMC team, through first filing (eg BLA) and into post-approval commercialization. The VPTs are cross-functional teams that interface closely with the external manufacturing network for execution of the program strategy.

Once a vector program need has been identified, the role will a) work closely with Strategic Sourcing and technical/quality functions to select the vector Contract Manufacturing Organization (CMO), and b) partner with Strategic Sourcing and Legal to put in place appropriate supply agreements. Once a CMO has been engaged for a program, the role will manage both the VPTs and well as the CMO relationship, ensuring that program objectives are met.

The role will work closely with the Vector CMC Strategy Team for the specific program, ensuring the strategy is clear and aligned before translating that strategy into executional objectives with the VPT and CMO. The Director-level grading for this role reflects the need for a strategic thinker who can negotiate difficult conversations with the CMO to meet the Celgene program objectives and who can distil trade-off decisions into recommendations for escalation to leadership. This role is ultimately accountable for successful execution of the vector program at a given CMO.

We are looking for a demonstrated leader with the breadth of professional experience and the drive to work with both internal and external partners to define and implement our vision, ensuring the right network partners are identified in a timely manner, and are subsequently managed appropriately to assure robust supply of Celgene cell therapy products. The right candidate will be strategic, highly-knowledgeable about cell therapy, have a solid technical operational background, and understand the challenges and impact of identifying, selecting, and managing CMO partners. As we are "changing medicine for good," we also need someone who is used to working in a highly matrixed and cross-functional organization, against tight and changing deadlines, and with world-class contract manufacturers and business leaders alike. The portfolio of CMOs and the VPTs that the successful candidate will manage will need to be flexible and responsive to accommodate the risks and changes associated with the highly novel technologies that Celgene will be investing in, as well as the different stages of various assets in the Celgene cell therapy pipeline.

The key deliverables for this role are to ensure reliable supply of our vector assets through:

  • Partnering with Strategic Sourcing in the identification and selection of world class Contract Manufacturing Organizations (CMOs), capable of commercializing Celgene technology and assets.
  • Providing the operational and business insight and drivers for negotiation and execution of contractual documents with CMOs (eg. confidentiality agreements, evaluation agreements, consulting agreements, master contract services agreements, development and manufacturing services agreements, and statements of work/task orders/change orders). The focus should be on innovative contracting, creating novel risk-sharing terms that embrace the fluidity associated with commercialization of novel technology.
  • Develop strong relationships with internal functional leaders, leveraging the right stakeholders for CMO due diligence, negotiations, investments, etc to assure the best outcome for Celgene's assets.
  • Build and maintain strategic relationships with Celgene's top vector CMOs.
  • Identify and escalate business-critical issues effecting Operations and Management to senior management as necessary, providing recommendations, mitigations and potential solutions.
  • Manage the VPTs, building high-functioning teams where team members are accountable as both functional as well as program representatives
  • Drive delivery of the vector program against aggressive timelines, including managing risks and issues that arise
  • Manage and coordinate post-approval lifecycle strategy implementation for vector programs, including establishing a robust business continuity program with strategic CMOs.

Primary Responsibilities

Engage with Celgene's development teams to understand pipeline program needs, with focus on vector. Partner with Strategic Sourcing and a cross-functional project team to identify the best CMO(s) for the program. Leverage internal subject matter experts for appropriate CMO due diligence to fully vet capabilities, risks and investments required. Partner with Strategic Sourcing and Legal to execute innovative contracts that protect Celgene's supply needs and IP, yet permit flexibility and risk-sharing with CMOs. After execution of a contract, act as contract monitor, ensuring both Celgene and the CMO deliver against the agreement. Act as team lead for the program VPT, setting the team priorities in alignment with the program needs. Ensure alignment of objectives and priorities with CMC Strategy Team, representing the VPT and CMO(s) in strategic decisions for the program. Act as the primary liaison with the CMO(s), manage CMO and Celgene expectations by disciplined tracking of scope and delivery against objectives; managing changes (documentation, alignment); controlling and managing budget; providing forecasts to CMOs; capturing performance against agreed metrics Live the Celgene values.

Required Qualifications

  • Bachelor's degree required, with a strong technical background in cell biology, immunology, or closely related discipline. Advanced Degree preferred.
  • 12+ years of experience working in biopharmaceutical manufacturing, supply chain, or pharmaceutical development.
  • Demonstrated ability to lead matrix teams; strong experience supporting best practices.
  • Demonstrated experience in management of CMOs
  • Strong quantitative and qualitative analytical abilities.
  • Ability to influence senior management both internally and externally.
  • Ability to expresses self clearly and concisely to key stakeholders; document issues and/or concerns concisely and comprehensively; assess options cross-functionally and articulate well-reasoned recommendations for leadership endorsement; adjust style, language and/or terminology appropriate for the audience.
  • Strong leadership and an innate ability to collaborate and build relationships is critical.
  • Strong background in technical operations, especially in aseptic environment.
  • Strong background in commercialization of new assets, through launch, and management of post-approval changes
  • Flexible and comfortable working with ambiguity as the program priorities follow the science and clinical outcomes
  • Zeal for innovation and problem-solving.

Education Requirements

  • Bachelor's degree in Life Sciences discipline appropriate to cell therapy programs (immunology, cell biology, genetic engineering, etc.).
  • Advanced degree in Life Sciences and/or an MBA preferred.