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
We are seeking an energetic, highly motivated, and creative project/vendor manager with experience in transferring analytical test methods to CMO partners.  The individual will have experience with drug substance and drug product assays as well as experience in fill/finish operations for sterile parenteral drug products.  The ideal candidate is a strong team player who has outstanding written, organizational, and oral communication skills and the ability to communicate and collaborate in an interdisciplinary environment.

Job Responsibilities
  • Actively manage vendors responsible for the testing of raw materials, starting materials, DS and DP (parenteral formulations). The primary focus of this role covers operations and logistics associated with sample shipment, work orders, scheduling of testing, and tracking vendor progress.  
  • Effectively negotiate Confidentiality Agreements, Master Services Agreements and Work Orders
  • Prepare, review and negotiate request for proposals
  • Work with company Business Operations to manage requisitions and financial matters associated with CMO operations (i.e., POs, change requests)
  • Monitor and verify implementation of company-controlled documents at CMOs
  • Assist in development of budgets and accurately report accruals to Finance
  • Support business reviews with CMOs and external partners
  • Effectively communicate issues to management and project teams
  • Organize and participate in daily teleconferences with CMOs; work closely with teams to manage deliverables.
  • Maintain outsourced project timelines and ensure progress against established dates
  • Onboard CMOs including integration into business systems
  • Ability to manage multiple programs/projects; sound organizational and time management skills
  • Identifies project issues such as resource, technical or scheduling constraints and assists to resolve these issues internally and with external stakeholders by development of risk assessments, summarized options and proposed solutions with impact statements.
  • Ensures that projects are completed on time, within budget and scope, and conforms to predetermined quality standards
Required Skills & Qualifications
  • 5+ years management experience in a biotech organization or relevant manufacturing environment and a BA/BS degree; MA, MS, PhD degrees may be considered.
  • Prior experience in outsourced development and manufacturing is required
  • Experience in manufacturing of raw materials, starting materials, drug substance and drug product (parenteral) is highly desired
  • Strong computer skills and experience project management software
  • Good understanding of activities related to the CMC development, with strong focus on Quality expectations of cGMP operations
  • Strong communication skills, good problem-solving abilities, and an ability to work effectively in a dynamic environment with a diverse team of co-workers
  • Ability to be flexible and responsive to change, be a results-driven problem solver.
Translate Bio is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.
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