Associate Director, Drug Product

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 raised $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 We are seeking an experienced and innovative Associate Director to lead drug product development and manufacturing efforts for oligonucleotide-based therapeutics, with an emphasis on novel delivery technologies (e.g., conjugates, or other non-viral systems). This role will be a key contributor to our CMC strategy and execution, supporting preclinical through clinical-stage programs, and working cross-functionally with internal and external partners. RESPONSIBILITIES Lead the design, development, and scale-up of drug product formulations for oligonucleotide-based therapeutics. Drive development of novel delivery systems to enable effective delivery to target tissues. Oversee drug product manufacturing activities at CDMOs, ensuring quality, timeline, and cost expectations are met. Author and review CMC documentation for regulatory filings (IND, IMPD, etc.), including formulation development reports, manufacturing protocols, and stability data. Collaborate cross-functionally with Development, Regulatory, Quality, and Clinical teams to ensure alignment and support program milestones. Evaluate and implement new technologies to improve formulation robustness, scalability, and manufacturability. Lead or support tech transfer activities and batch manufacturing oversight at GMP facilities. Manage external vendors and CDMO relationships, including budgeting, contracts, and performance monitoring. Contribute to CMC strategy and risk management, helping shape the development path for novel therapeutics. QUALIFICATIONS PhD or MS in Pharmaceutical Sciences, Chemical Engineering, Biotechnology, or related discipline. Minimum of 8+ years (PhD) or 10+ years (MS) of experience in drug product development, preferably with oligonucleotide modalities. Deep expertise in formulation science, sterile drug product development, and novel delivery systems. Demonstrated success leading external CDMO/CRO activities and overseeing GMP manufacturing. Strong understanding of regulatory expectations for oligonucleotide-based drug products. Excellent communication, leadership, and project management skills. Experience working in a fast-paced, early- to mid-stage biotech or pharma environment is highly desirable. Experience with both liquid and lyophilized formulations. Familiarity with analytical characterization of oligonucleotide formulations. Prior experience supporting clinical trial material (CTM) manufacturing and release. Knowledge of quality systems, ICH guidelines, and GMP requirements. 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.

Created: 2025-09-24