Director, Manufacturing and Process R&D

Posted on April 29,

Orna Therapeutics, Inc. is a Cambridge-based biotechnology startup on a mission to create therapies for diseases inaccessible to existing approaches. Built on novel circular RNA technology developed at MIT, Orna is leading the next wave of RNA therapeutics with our best-in-class expression and delivery platform. We are seeking an exceptional Director, Manufacturing and Process R&D to join our team. The candidate will report to the SVP, CMC and lead manufacturing process development, scale up, and clinical manufacturing activities for Orna’s circular RNA and lipid nanoparticle candidates. They will be responsible for developing platform capabilities for manufacturing of drug substance and drug product at scale, developing GMP-compatible processes, and leading GMP manufacturing activities. Furthermore, they will have experience leading small and medium sized teams, possess strong oral and written communication capabilities, demonstrate excellent collaboration and interpersonal skills, and be adept at problem solving in a fast-paced environment.

Responsibilities

  • Lead manufacturing process development activities for circular RNA and lipid nanoparticle candidates.
  • Manage a team of process development scientists to design and implement manufacturing and scale-up strategies.
  • Design and implement GMP-compatible manufacturing processes, including identification of critical process parameters and in-process tests. Oversee internal and external manufacturing activities, including scale-up and external technology transfer to CDMOs.
  • Work with supply chain, QA, and CMC functions to oversee manufacturing of test article(s) for preclinical/GLP studies and clinical trial materials for Phase 1/2 clinical studies.
  • Implement scale-appropriate manufacturing solutions company-wide and work cross-functionally to integrate new platform capabilities. Lead transition from preclinical to clinical-scale manufacturing for product candidates.
  • Generate, interpret, and present data to cross-functional R&D teams, and author/review regulatory filings.
  • Contribute to a positive and exciting work environment; contribute to a strong entrepreneurial and creative culture.

Qualifications

  • PhD + 10 years industry experience or equivalent abilities in chemical engineering, biomedical engineering, chemistry, biology, or related field
  • 10+ years of experience developing pharmaceutical manufacturing technologies in a GMP environment. Experience in nucleic acid, large molecule or novel biomanufacturing technologies preferred.
  • Experience developing and implementing phase-appropriate GMP manufacturing processes and overseeing external CDMO partners.
  • Experience managing small and medium-sized teams, with strong people leadership and mentoring skills.
  • Experience working with cross-functional product development teams, including research, supply chain, pharmaceutical development, QA, and regulatory.
  • Nanoparticle manufacturing experience preferred.
  • Highly organized and can collaborate on execution of multiple parallel initiatives.
  • Detail oriented, self-motivated, and excited to take on new challenges!

Website: https://www.ornatx.com/
Orna Therapeutics, Inc.is an equal opportunity employer.