External Manufacturing and Supply Chain Lead

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 External Manufacturing and Supply Chain Lead to join our team. The candidate will manage supply chain and external manufacturing activities for Orna’s circular RNA and lipid nanoparticle candidates. Primary responsibilities include working with internal stakeholders and third-party partners to plan external manufacturing and supply chain activities, ensuring timely delivery of of materials and coordination of CRO services, and acting as the primary liaison with external suppliers, logistics providers, and test/manufacturing partners. The ideal candidate will have extensive experience working with a variety of CDMOs for cell and gene therapy or nanoparticle applications and working with internal R&D, CMC and other teams. Furthermore, the candidate will possess strong oral and written communication capabilities, demonstrate excellent organization, collaboration, and interpersonal skills, and be adept at problem solving in a fast-paced environment.

Responsibilities

  • Work closely with the SVP, CMC and other team members to develop, support and facilitate a comprehensive supply chain and manufacturing strategy for Orna’s circular RNA and lipid nanoparticle candidates
  • Help identify, engage, and manage relationships with vendors and external manufacturing/testing partners
  • Be responsible for all logistics regarding procurement, release, testing, storage, and shipping of raw materials, Drug Substance, and Drug Product.
  • Help oversee manufacturing and testing activities at CDMO partners, including non-GMP and GMP activities, for circular RNA and lipid nanoparticle candidates.
  • Resolve any issues impacting timelines or other critical deliverables, communicate potential impact(s) to management and other key stakeholders, and assist in mitigation plans.
  • Work with CMC leadership and SMEs to ensure adequate support for technology transfer and process development at 3rd parties, where applicable
  • Work with CMC and QA functions to coordinate release and shipment of test article(s) for preclinical/GLP studies and investigational products for clinical studies.
  • Work with QA and other stakeholders to review data, interpret results, and address Quality issues, e.g. CAPAs, OOS, OOT, deviations/investigations, etc., that might arise.
  • Contribute to regulatory filings as needed.
  • Contribute to a positive and exciting work environment; contribute to a strong entrepreneurial and creative culture.

Qualifications

  • 7+ years of experience in managing supply chain(s) and external manufacturing activities in a GxP environment. Significant experience working with new process development and/or pharmaceutical manufacturing technologies.
  • Significant familiarity with GMP/GCP/GLP environments, technology transfer, and establishing logistics processes and inventories
  • Experience with nucleic acid products, nanoparticles, large molecules or new modalities preferred.
  • Ability to interpret and troubleshoot data, with excellent problem-solving skills.
  • Experience working productively with small and medium-sized teams
  • Experience working with cross-functional product development teams, including Research & Development, QA, Pre-clinical and Safety, Regulatory Affairs, and other groups.
  • 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.