Associate Director: Oligonucleotide DP & CMC (Hybrid)

Airna; Cambridge (MA); Hybrid; USD 180,000 - 260,000; Full time

Job summary

AIRNA in Cambridge, MA is seeking an experienced Associate Director to lead drug product development for oligonucleotide therapeutics, focusing on novel delivery technologies and cross-functional collaboration with internal and external partners.

The role covers preclinical through clinical-stage programs, overseeing GMP manufacturing, and authoring regulatory CMC documents to support IND, IMPD filings. A strong background in formulation science and CDMO management is essential.

Qualifications

• PhD or MS in Pharmaceutical Sciences or related discipline required.
• 8+ years (PhD) or 10+ years (MS) in drug product development.
• Experience with oligonucleotide modalities is preferred.
• Strong leadership and cross-functional collaboration.

Responsibilities

• Lead design, development, and scale-up of drug product formulations.
• Drive development of novel delivery systems for targeted tissues.
• Oversee drug product manufacturing at CDMOs, ensuring quality, timeline, cost.
• Author and review CMC documentation for regulatory filings (IND, IMPD, etc.).
• Collaborate cross-functionally with Development, Regulatory, Quality, and Clinical teams.
• Evaluate and implement new technologies to improve formulation robustness and manufacturability.
• Lead or support tech transfer and batch manufacturing oversight at GMP facilities.
• Manage external vendors and CDMO relationships, including budgeting and contracts.
• Contribute to CMC strategy and risk management.

Skills

Formulation science

Sterile drug development

CDMO management

Regulatory understanding

Leadership

Project management

Analytical characterization

CTM manufacturing

Education

PhD or MS in Pharmaceutical Sciences or related field

Tools

GMP experience

Job description

AIRNA in Cambridge, MA is seeking an experienced Associate Director to lead drug product development for oligonucleotide therapeutics, focusing on novel delivery technologies and cross-functional collaboration with internal and external partners.

The role covers preclinical through clinical-stage programs, overseeing GMP manufacturing, and authoring regulatory CMC documents to support IND, IMPD filings. A strong background in formulation science and CDMO management is essential.