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Senior Director of Process Development and Innovation

2 months ago

Trenton, New Jersey, United States Jobot Full time
About the Role

We are seeking a highly experienced Senior Director of Process Development to join our team at Jobot. As a key member of our organization, you will be responsible for leading the development of robust, high-performing processes for gene therapy applications, ensuring compliance with industry standards and regulations.

Key Responsibilities
  • Develop and implement process development strategies for gene therapy candidates, from early stages through regulatory approval.
  • Lead a team of scientists to design, scale-up, and transfer manufacturing processes for clinical gene therapy vectors.
  • Collaborate with cross-functional teams to execute innovative process development projects, leveraging scientific expertise and literature review.
  • Provide strategic guidance for departmental and site operations, ensuring alignment with company goals and objectives.
  • Serve as the primary interface for process development, technology transfer, and validation activities, facilitating seamless communication with stakeholders.
  • Develop and maintain relationships with contract manufacturing partners, ensuring successful technology transfer and validation of gene therapy candidates.
  • Lead CMC activities for regulatory filings and interactions, ensuring compliance with industry standards and regulations.
  • Direct the design, scale-up, and technology transfer of manufacturing processes, optimizing efficiency and productivity.
  • Oversee process characterization and validation strategies, ensuring data integrity and compliance.
  • Prepare development reports, transfer documents, and regulatory submissions, ensuring accuracy and completeness.
  • Manage CDMO development operations, ensuring timely and cost-effective delivery of gene therapy candidates.
  • Contribute to project proposals, timelines, and work plans, ensuring alignment with company goals and objectives.
  • Prepare manuscripts and present findings at scientific conferences, showcasing expertise and thought leadership.
Requirements
  • Advanced degree (PhD) in chemical engineering, biochemical engineering, or a related scientific discipline.
  • Minimum 10 years of experience in process development in the Life Sciences space, with a strong focus on gene therapy, leadership, cGMP manufacturing, and regulatory filings.
  • AAV Gene Therapy experience is required, with late-phase experience being ideal.
  • Strong technical skills, with a deep understanding of process development principles and techniques.
  • Excellent problem-solving skills, with the ability to think strategically and make sound decisions.
  • Strong communication skills, with the ability to effectively convey complex technical information to various audiences.
  • A commitment to continuous learning and improvement, with a passion for staying up-to-date with the latest scientific and technological advancements.