Company Overview
We are a leading mRNA therapeutics company developing a new class of potentially transformative medicines to treat diseases caused by protein or gene dysfunction. Using our proprietary mRNA therapeutic platform (MRT), we create mRNA that encodes functional proteins. Our mRNA is delivered to the target cell where the cell’s own machinery recognizes it and translates it, restoring or augmenting protein function to treat or prevent disease.

At Translate Bio, we’re also passionate about our five core values: Put People First, Be Approachable, Act as One, Be Tenacious, and Be Bold. These values embody our culture and underscore our mission to bring mRNA therapeutics to all.

Job Summary
This role will be responsible for Translate Bio’s relationship and oversight of raw material vendors and service providers to support Translate Bio program goals and deliverables. This role will also lead new vendor selection initiatives. It will also partner with internal key stakeholders and vendors to ensure tech transfer and project deliverables are met to support all raw material requirements for drug substance and drug product manufacturing.  

Job Responsibilities
  • Act as primary liaison with CMOs and suppliers to ensure raw material supplies meet demand needs for drug substance, bulk drug product, and fill/finish manufacturing operations. This will include creating and managing the project plans with CMOs, coordinating the project deliverables, actions and review and approval of documents from responsible functions to ensure uninterrupted supply.
  • Lead raw material sub-teams to ensure all raw material requirements are defined, production and project activities progress per timelines and any risks and issues are escalated to CMC teams. 
  • Manage vendor identification and selection process for new raw material vendors. This will include initiating CDAs, drafting Requests for Proposals, vendor evaluation and selection, negotiating favorable pricing, supply agreements or in-licensing opportunities with vendors as appropriate.
  • Oversee and ensure success of Tech Transfer (TT) activities from Translate to CMO partners. This will include development of a comprehensive tech transfer plan and schedule, ensuring alignment with the drug substance and drug product needs, review and approval of raw material/consumables procurement plans, and coordination with Analytical Development on analytical method transfer / qualification / validation.
  • Manage Vendor Change Notifications (VCN), generation and closeout of Change Controls for VCNs, and inventory management with respect to VCNs.
  • Create and manage required Purchase Orders, Statement of Works, review and approve invoices as needed. 
  • Establish and manage overall relationships with raw material vendors and service provides. Manage vendor performance and delivery of products on a regular basis. Create KPIs and scoreboards to monitor performance. 
  • Help with vendor management investigations, overall manufacturing strategies, support of IND activities, production planning and release activities etc. as needed. 
  • Assume additional responsibilities as assigned.  
Required Skills & Qualifications
  • Bachelor’s degree in a scientific field, business or related field with minimum 8+ years of pharmaceutical or biotech industry. Master’s degree preferred.
  • Experience in vendor management, project/relationship management, leading cross-functional teams and/or tech transfers in early and late development phases within pharmaceutical industry. 
  • Strong knowledge of project management tools/software and digital solutions. 
  • Must demonstrate competencies of strategic thinking, influencing, innovation and leadership.
  • Excellent communication (verbal and written) and organizational skills
  • Ability to manage multiple projects in a fast-paced environment
Translate Bio is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.
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