Project Manager Associate CMC

About us

Asklepios BioPharmaceutical, Inc. (AskBio) is a privately held AAV gene therapy-based company founded in 2001 in response to parents and patient advocates seeking treatment for rare, genetically derived and life-threatening childhood illnesses.  AskBio’s scientific platform is based on the work of Dr. Jude Samulski and Dr. Xiao Xiao. The Company’s history has been largely mission driven to help patients without other options; AskBio carries on this patient-focused mission today. We are headquartered in Research Triangle Park, North Carolina.

We are seeking a CMC Project Manager Associate to join the AskBio team.

Responsibilities

  • Interfaces with project teams and external suppliers, as necessary, to plan and coordinate timely execution of CMC activities
  • Responsible for project logistics and documentation. Uses key project management tools to drive project delivery and information dissemination to key stakeholders
  • Responsible for the maintenance of requisite project documentation to ensure delivery of the overall CMC plan and milestones
  • Assist in the evaluation of clinical and non-clinical material demand to provide appropriate planning, coordination and communication to enable timely supply of materials
  • Communicates effectively with process and analytical development, manufacturing, clinical project managers, project leads, and with all interfacing functions and relevant governance bodies, as required
  • Ensures production and maintenance of project documentation to ensure delivery of the overall CMC plan and milestones
  • Anticipates operational issues at the project level, and, working within the cross-project community,  influences solutions for similar issues in other projects
  • Provide critical input to Project Management for proactive resolutions and improvements

About you

  • Bachelor’s, Master’s, or equivalent industry experience in a relevant technical discipline such as biochemistry, molecular biology, microbiology, genetics, immunology or chemical engineering. Relevant training (PMP or equivalent) or experience in project management is a preferred
  • For Associate Project Manager: 1 year of project management experience (preferably in CMC) is preferred, and for Project Manager: 1-2 years of project manager experience (preferable in CMC) is required
  • Understanding of biologics CMC development and manufacturing
  • Successful candidate must have experience in planning and managing the cross functional aspects of biopharmaceutical product development
  • Must be self-motivated, organized, capable of working independently, as well as in a collaborative/group environment
  • Experience with global teams, especially Spanish speaking, a plus
  • Comfortable with ambiguity. Must be professional, dedicated and detail orientated
  • Excellent oral and written communication, interpersonal, analytical and computer skills
  • Effective problem solving and analytical skills to tackle and manage a broad range of issues and projects and deliver innovative solutions
  • Ability to understand scientific data
  • Hands-on experience working in one of the CMC functions
  • Familiarity with Microsoft Project is preferred
  • Project Management Professional (PMP) or equivalent certification

 AskLife™
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