Location

Cambridge, MA
United States

Associate Director/Director, Analytical Development

COMPANY OVERVIEW

AIRNA is a biotechnology company with a mission to be the leading RNA editing company delivering precision therapies to patients with rare and common diseases.

AIRNA is harnessing advances in genetics to develop transformative RNA-editing medicines that improve human health. Our proprietary platform is based on groundbreaking research by pioneers of the field and company co-founders Thorsten Stafforst (University of Tübingen) and Jin Billy Li (Stanford University) and enables optimal potency, safety, and delivery. AIRNA is advancing a robust pipeline of therapeutic candidates that are designed to provide functional cures for severe or chronic diseases by repairing harmful genetic variants or introducing beneficial variants promote optimal health.

AIRNA has received $245 million in financing from a world-class syndicate of investors including Arch Venture Partners, Forbion, Venrock Healthcare Capital Partners, RTW Investments, Nextech Invest, and ND Capital. We value teamwork, resilience, excellence, human, and health, and have a diverse team at both our headquarters in Cambridge, MA and our research operations in Tübingen, Germany.

JOB DESCRIPTION

The Associate Director/Director, Analytical Development will be a key role in our development team, providing support across all developmental and clinical programs. This role is critical in ensuring the successful transition of an oligonucleotide therapeutic from development to commercial-scale production while maintaining high standards of quality and compliance. The successful candidate will be involved in managing the analytical development and quality control at a network of CMOs for Drug substance and Drug Product manufacturing for AIRNA’s pipeline.

RESPONSIBILITIES

Leadership in Analytical Development:

  • Provide leadership and technical expertise in the analytical development of methods for the testing and release of oligonucleotide drug substance and drug product.
  • Ensure robust analytical methods are developed to characterize and validate oligonucleotide products at various stages of development.

Overseeing CMO Relationships:

  • Manage and oversee the work done by CMOs involved in the testing of oligonucleotides, ensuring quality and timely delivery of materials.
  • Work closely with CMOs to ensure the successful development of analytical methods and release of non-GMP and GMP drug substance and drug product.
  • Ensure compliance with Good Manufacturing Practices (GMP), regulatory requirements, and internal standards at CMOs.

Collaboration with Cross-Functional Teams:

  • Collaborate with internal teams such as regulatory affairs, quality assurance, and process development to ensure analytical activities are aligned with the overall project timelines.
  • Work with regulatory teams to support filings and prepare data for regulatory submissions (IND, BLA, etc.).

Problem-Solving and Risk Mitigation:

  • Identify and address any analytical or technical challenges during the development and manufacturing processes.
  • Evaluate and mitigate risks related to the CMO’s capabilities, timelines, and quality control.

Quality Control and Compliance:

  • Ensure all analytical methods are validated and meet the regulatory requirements (e.g., ICH, FDA, EMA guidelines).
  • Perform regular quality checks and audits to ensure that CMOs meet the required product specifications.

QUALIFICATIONS

  • M.S. or Ph.D. in Chemistry, Biochemistry, or related discipline
  • Minimum of 8 years’ experience in analytical development of oligonucleotide therapeutics
  • In-depth knowledge of oligonucleotide chemistry, analytical techniques (HPLC, MS, electrophoresis, etc.), and their application in drug development
  • Previous experience managing analytical activities at CMOs for outsourced manufacturing
  • Preferred experience with analytical test methods of oligonucleotides
  • Strong understanding of phase appropriate analytical development for oligonucleotides
  • Experience with US and EU CMC regulatory expectations
  • Ability to troubleshoot complex technical issues and implement solutions in a timely manner
  • Previous experience working in small biotech

LOCATION AIRNA has a hybrid work model, and the role will be based in AIRNA’s corporate headquarters in Cambridge, MA ~3 days per week.

To apply for for this position, please send your cover letter and CV to [email protected].

  Back to Careers