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Associate Director/Director, External Manufacturing, Cell Therapy


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Job Details

Location: Cambridge, Middlesex County, Massachusetts, USA Posted: Jun 24, 2020

Job Description

Job Summary

The primary focus of the Associate Director/Director, External Manufacturing, Cell Therapy role is to build and lead ‘virtual plant teams’ (VPTs), that interface closely with the Bristol Myers Squibb external manufacturing network as well as internal stakeholders, to ensure flawless execution of the Bristol Myers Squibb vision. We are looking for a leader with the breadth of professional experience and the drive to work with both internal and Contract Manufacturing Organizations (CMOs) to define and implement our plans.

The candidate will be responsible for ensuring the right network partners are identified in a timely manner and are subsequently managed appropriately to assure robust supply of cell therapy products. The right candidate should have proven experience in implementation of strategic initiative in dynamic business environment, a solid technical operational background, and understand the challenges and impact of identifying, selecting, and managing CMO partners. The candidate should be able to adapt to risks/changes associated with the highly novel technologies and distill trade-off decisions into recommendations for escalation to leadership/negotiation with CMOs, to meet the BMS program objectives. The successful candidate will be ultimately responsible for successful execution of the vector manufacturing strategy at the CMO site(s).

As we are “changing medicine for good,” we are looking for leaders who can work in a highly matrixed and cross-functional organizations, against tight deadlines, and with world-class contract manufacturers and business leaders alike.

Primary Responsibilities

  • Lead high-functioning VPTs where cross-functional team members are accountable, as both functional as well as program representatives, for prioritization and execution the BMS strategy
  • Drive delivery of the vector program against aggressive timelines by anticipating and managing risks and proactively developing mitigation plans
  • Develop and maintain strong strategic relationships within the CMO organization to ensure the best outcome for Bristol Myers Squibb assets
  • Partner with key stakeholders to establish a vendor management/governance program to track and report compliance with commitment in existing agreements (including but not limited to SoWs, commercial and clinical supply agreements and quality agreements)
  • Identify and escalate business-critical issues effecting CMO operation/management to senior management with recommendations around potential solutions
  • Partner with CMOs and internal stakeholders to draft, manage, and deliver on annual CMO performance targets, and operating budget.
  • Manage and coordinate post-approval life-cycle strategy implementation, including a robust business continuity program for the CMOs.
  • Ensure alignment of objectives and priorities with CMC Strategy Team, representing the VPT and CMOs in strategic decisions for the program.
  • Collaborate with CMO and internal stakeholders to understand planned change and manage the E-2-E implementation process
  • Act as the primary liaison with the CMOs to manage expectations by disciplined tracking of scope and delivery against objectives/metrics including but not limited to quality, regulatory, safety and environmental compliance, robust and timely supply, change management and budget/spend management
  • Engage with Bristol Myers Squibb development teams to understand requirements of the asset/technology pipeline and collaborate with cross functional stakeholders in the development of a world class CMO network to support the commercialization of the same
  • Provide business insight for negotiation and execution of contractual documents with CMOs – focus on creating risk-sharing frameworks to support the fluidity associated with novel technologies
  • Live the Bristol Myers Squibb values

Required Qualifications

  • 10+ years of experience working in bio-pharmaceutical 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
  • Strong leadership and an innate ability to collaborate and build relationships is critical
  • Ability to expresses one’s self clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience
  • Strong background in technical operations – experience in aseptic operations preferred
  • Experience 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 or related discipline (Immunology, Microbiology, Cell Biology, Engineering, etc.).
  • Advanced degree in Life Sciences and/or MBA preferred

About Celgene

Celgene discovers, develops and commercializes innovative therapies to treat cancer and immune-inflammatory-related diseases.

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