Project Coordinator, CMC

2 months ago

King of Prussia, United States Franklin Biolabs Full time

As a Contract Research Organization (CRO), Franklin Biolabs is redefining the landscape of the global genetic medicines industry by providing a full range of services from discovery to clinical vector manufacturing. With decades of expertise and a steadfast commitment to excellence, we bridge the gap between groundbreaking research and the delivery of transformative therapies to patients with severe and disabling diseases.


With a focus on disruptive solutions to advance the gene therapy industry, the company will provide specialty services in immunology, vector production and analytics, next generation sequencing and bioinformatics, and nonclinical pharmacology/toxicology studies.


Franklin Biolabs is led by gene therapy industry pioneer Jim Wilson and his team of experts, who previously conducted their work in academia. Wilson is also the President and CEO of GEMMABio, a therapeutics company. The collective goal of the two affiliated companies is to translate innovative scientific work into clinical trials, to then commercialize and distribute the new therapies around the world to patients who need them most.


Job Summary

As the Project Coordinator, CMC you will assist the development of internal and external CMC project plans and strategy for Franklin Biolabs programs. As a Project Coordinator, Vector Project Management, you will assist in communication management for CMC cross-functional projects among Franklin Biolabs personnel, and between Franklin Biolabs and external parties such as Contract Manufacturing Organizations (CMOs). You will monitor and coordinate activities as it pertains to supply chain, budgets, and milestones tracking. As applicable, you will coordinate the stand up and management of various tools in support of the manufacturing process and/or analytics, associated financial practices, regulatory requirements/compliance and continuous improvement as it pertains to CMC project workstreams.


Qualifications:

  • Bachelor's Degree (preferably in scientific field or engineering) with 1-2 years of experience in biotech or pharmaceutical fields or an equivalent combination of education and experience is required
  • Must work efficiently aligning actions to project targets, milestones, and priorities
  • Must have excellent communication skills, with the ability to provide clear, audience-focused descriptions of CMC tasks and issues, and proposed solutions to schedule challenges, all done in an open and honest manner
  • Demonstrated ability to facilitate project team meetings, enhance cross-functional communication, support decision making, and ensure alignment among internal (and sometimes external) stakeholders.
  • Preferred experience in process development and process transfer, focused on biologics, viral vectors, or vaccines
  • Preferred experience in external vendor search, selection and management
  • Proficiency with Microsoft Office suite (e.g. Word, Excel, PowerPoint, Project, Outlook)
  • Proficiency with cloud-based project management information systems (PMIS) and graphical displays of project information (e.g. dashboards, resource charts, etc.)


Application note

Franklin Biolabs is not accepting unsolicited resumes from search or staffing firms. All resumes submitted by search or staffing firms to any employee at Franklin Biolabs via email, the Internet, or directly without a valid written search agreement for this role will be deemed the sole property of Franklin Biolabs and no fee will be paid in the event the candidate is hired.

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