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Associate Director / Director of Process Development

Company: Klein Hersh International
Location: Durham
Posted on: April 10, 2021

Job Description:

Associate Director / Director of Process Development Our client is founded by pioneers in ocular gene therapy and is a clinical-stage gene therapy company focused on leveraging genetic medicine to reverse or prevent blindness. The company has an ongoing Phase I/II clinical trial evaluating a potential therapy for one of the most common causes of blindness in children. Its pipeline of clinical and preclinical assets is powered by adeno-associated virus (AAV) technology. The successful candidate will lead and manage a team of process and analytical development scientists responsible for the development, optimization and characterization of AAV manufacturing platform to supply our next generation AAV vectors supporting early and late-stage development programs. Reporting to the Vice President, CMC, the candidate will be responsible for functional leadership of the process development team. The team will collaborate to ensure the development, transfer, and characterization of robust processes used for both clinical and commercial production. Job Responsibilities

  • Lead the Process Development group to develop globally compliant, robust, well-characterized, scalable and high quality AAV production platform to support both internal and external (CDMO) manufacturing requirements for preclinical, clinical and ultimately commercial programs.
  • Recruit, manage, train and retain a motivated and capable process development team; establishing and managing performance to individual and corporate goals.
  • Collaborate and work cross-functionally with internal and external Development, Manufacturing, Regulatory Affairs, and Quality functions to ensure all activities are scheduled and executed on time in accordance with program timelines.
  • Identify, evaluate and implement novel technologies and systems in the development of the Company's manufacturing and analytical platforms.
  • Participate in the transfer of technology to contract development and testing organizations to ensure the successful and precise execution of activities. Includes routine support of CDMOs to maintain reliable supply.
  • Work with departmental leadership to develop and implement standard work practices to ensure a safe and compliant working environment.
  • Ensure the generation and documentation of all scientific data and technical reports are managed in compliance with best data integrity practices.
  • Prepare and review of regulatory and CMC documents, including authoring of module 3 sections of regulatory submissions. Job Requirements
    • BS/MS with 15+ years of relevant experience or PhD in Chemical Engineering or Biological/Biochemical sciences with 10+ years of relevant experience in AAV gene therapy.
    • Demonstrated experience with track record of success leading upstream and downstream technical teams, experience in process scale up and development of scale down models. Advanced knowledge of DOE principles and process characterization experience.
    • In-depth technical understanding of process development and process and analytical validation in viral vector manufacturing.
    • Demonstrated cross-functional leadership and ability to work with teams to drive results. Proficiency in strategic planning, cross-functional performance management, people management, and technical leadership.
    • Proven leadership experience and strong people management skills with the desire and ability to deliver on objectives while developing people in a dynamic and fast-paced environment.
    • Strong team building, organizational, collaboration and communication skills.
    • Excellent written and verbal communication skills; strategic thinker with strong problem-solving skills and effective interpersonal communications.
    • Established experience with tech transfer to multiple CDMOs is a plus.

Keywords: Klein Hersh International, Durham , Associate Director / Director of Process Development, Executive , Durham, North Carolina

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