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Job Title: Manager, Program Management, CMC

Job Number: 25130

Location: Lexington, MA

Job Description

We are seeking a highly motivated and experienced individual to join our team as a Manager, Program Management. The successful candidate will report to the Senior Director of Program Management and will be an integral part of the Program Management and Technical Operations teams.  This position offers opportunities to work with multiple external CROs, CTOs, and CMOs.

Responsibilities

  • Facilitate communication among team members and coordinate activities to drive project execution in alignment with defined schedule. Collaborate with multi-disciplinary team members to develop integrated project plans and lead regular meetings to track activities, monitor progress, drive decision making, resolve issues, and identify risks and mitigation plans. 
  • Align with internal team members to ensure completion of deliverables supporting manufacturing campaigns. Ensure integration of activities into overarching project plan. Manage projects outsourced to multiple CROs / CTOs / CMOs. Assist with preparation of RFPs and drive contract development, review and approval. Plan activities/deliverables and establish timelines, monitor progress, resolve issues, and identify risks and mitigation plans.
  • Proactively manage raw material supply chain for drug substance and drug product production. Coordinate with multiple vendors to order required raw materials and monitor outstanding deliveries. Develop long term supply chain forecast aligned with CMC production forecasts to ensure maintenance of reagent supply and identify / mitigate pinch points.
  • Develop project/program and manage spending against established budget.

Required Skills

  • Bachelor’s or Master’s degree in life sciences, biotechnology or engineering with expertise in program or project management.
  • 5+ years (Bachelor’s) / 3+ years (Master’s) experience in a similar position, 5-7 total years’ experience in the biotechnology / pharmaceutical industry.
  • Demonstrated ability to facilitate project team meetings, enhance cross-functional communication, support decision making, influence outcomes, and ensure alignment among internal and external stakeholders.
  • Excellent organizational skills with great attention to detail coupled with strong interpersonal skills, self-awareness and ability to manage team dynamics.
  • Ability to effectively represent the Company to external partners, CROs, CTOs and CMOs.
  • Excellent knowledge with all aspects of MS Office including Visio and MS Project.
  • Excellent communication skills and ability to provide clear, candid, and transparent descriptions of CMC/technical tasks, issues, schedule challenges, and proposed solutions.
  • Able to achieve goals in a timely manner, despite obstacles, by prioritizing tasks and building in contingency planning.

Translate Bio is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

 

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