Director, Pharmaceutical Development

Posted on May 25,

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, Pharmaceutical Development to join our team. The candidate will report to the SVP, CMC and work cross-functionally to lead key product development activities for Orna’s products. Specific responsibilities include contributing to Orna’s overall pharmaceutical development strategy, leading internal analytical and drug product development teams, and authoring/contributing to applicable sections of regulatory filings. The ideal candidate will have significant experience in early-stage product development (preclinical to Phase 2) for complex pharmaceutical products, including experience developing and evaluating suspension formulations and selecting appropriate container closure systems for clinical-stage products. They will be able to quickly develop and implement phase-appropriate product development solutions, demonstrate excellent collaboration and interpersonal skills, and be adept at problem solving in a fast-paced environment.

Responsibilities

  • Lead analytical and formulation functions and ensure robust cross-functional collaboration.
  • Collaborate closely with senior management and internal SMEs to develop formulation and analytical development strategies for Orna’s circular RNA products.
  • Manage a team of cross-functional direct reports across analytical development and formulation development functions. Collaborate closely with peer groups in process development, supply chain, and QA.
  • Oversee implementation formulation and analytical development activities to support broader product development.
  • Manage external CRO/CDMO partners and oversee tech transfer activities, where appropriate.
  • Generate, interpret, and present data to cross-functional R&D teams.
  • Author/review analytical and pharmaceutical development sections of regulatory filings.
  • Contribute to a positive and exciting work environment; contribute to a strong entrepreneurial and creative culture.

Qualifications

  • PhD+ 10 years pharmaceutical or biotechnology experience, MS+15 years industry experience or equivalent in chemistry, molecular biology, biochemistry, engineering, or related field
  • 10+ years of experience in pharmaceutical development, including experience developing critical quality attributes and quality target product profiles for new technologies or new therapeutic modalities
  • Experience with nanoparticles and/or complex particle products preferred
  • Experience leading department-level teams in analytical and/or formulation development
  • Broad familiarity with cross-functional pharmaceutical development activities, with a track-record of developing clinical-stage products in multi-functional teams (Research and Development, Preclinical, Safety, Clinical)
  • Experience authoring regulatory documents
  • 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.