Manager, CMC Project Management

Translate Bio

Lexington, MA, US
  • Job Type: Full-Time
  • Function: Manufacturing
  • Post Date: 03/21/2021
  • Website: translate.bio
  • Company Address: 790 Memorial Drive Suite 203, Cambridge, MA, 02139

About Translate Bio

Translate Bio is focused on pioneering the translation of RNA science into therapeutics promoting healthy gene expression in people living with debilitating genetic diseases. The company’s RNA platforms for powering endogenous therapeutic protein production is applicable to a broad range of diseases caused by insufficient protein production, including rare diseases of the liver, lung and central nervous system (CNS).

Job Description

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

The Manager of CMC Project Management will be responsible for program and project management functions for the Technical Operations team, which includes all Chemistry, Manufacturing, and Controls (CMC) activities for Translate Bio’s programs from GLP toxicology through commercial manufacturing and supply.  The ideal candidate will have significant relevant experience and a track record of accomplishments in the life sciences/pharmaceutical/biotechnology industry. This role is part of a team focused on development and manufacturing of a novel mRNA technology.
 
The successful candidate is expected to have a technical background (8+ years of industry experience) in formulation development, process engineering, or chemistry with additional industry experience in program management in the pharmaceutical or biotech field developing clinical and commercial candidates.

Job Responsibilities

  • Lead cross-functional CMC teams to develop and execute the CMC strategy from development candidate through IND and commercial for both internal and external projects.  
  • Collaborate with multi-disciplinary team members to develop the integrated project plan and lead regular cross-functional meetings to track activities, monitor progress, drive decision making, resolve issues, and identify risks and mitigation plans.
  • Apply project management expertise and best practices in the planning, initiation, execution, and tracking of project activities.  Organize and facilitate Gantt charts and manage timeline, particularly critical path items.  Develop and maintain project charters, RACI matrixes, resource trackers, and project budgets.
  • Proactively monitors project progress to ensure communication on project/program strategy status, critical path activities, resource requirements, risks and mitigation strategies are identified early and communicated effectively
  • Develop project/program budgets and manage spending against established budget.
  • Represent the CMC team on Program Teams and ensure alignment of the CMC strategy and timeline with non-clinical, clinical, and regulatory teams.  
  • Participate in the development, implementation, and sustainability of standardized approaches to program/project management. 
  • Assume additional responsibilities as assigned.  

Required Skills & Qualifications

  •  5-8+ years of relevant experience in the biopharmaceutical industry.
  • College or advanced degree in chemical, biomedical, biochemical, or process engineering, chemistry, materials sciences, or formulation sciences, coupled with an understanding of analytical chemistry.  Advanced degree in business or management is not required but preferred.
  • Strong written and oral communications skills, with demonstrated experience in cross-functional and timely communication.  Strong and collaborative work ethic; must be a self-starter and persistent in achieving objectives to support Translate Bio’s scientific and business goals.
  • Highly organized, exceptional attention to detail, and strong proficiency in documentation skills.
  • Must work well in a small team setting, with the ability to work independently and collaboratively, while meeting scheduled deadlines in a fast-paced environment
  • Results-oriented and demonstrates a focus on achieving (business) results.
  • Demonstrated ability to facilitate project team meetings, enhance cross-functional communication, support decision making, influence outcomes, and ensure alignment among internal and external stakeholders.
  • Familiar with current issues and Regulatory requirements related to manufacturing using single-use equipment for drug substance and drug product production.
  • Knowledge and understanding of laboratory terminology, good documentation, and good laboratory practices.  Experience and demonstrated proficiency in global GxPs, industry guidance (esp., ICH Q6 – Q12) and compliance with the same.
  • Demonstrated success in managing multiple projects effectively. Excellent organizational skills with great attention to detail.
  • Strong interpersonal skills, self-awareness and ability to manage team dynamics.
  • Ability to effectively represent the Company to external partners, CROs, CTOs
  • Excellent knowledge with all aspects of MS Office including Visio and MS Project.
Translate Bio is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.