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Myrna

Pharmaceutical Drug Consultant

Summary

Myrna is a pharmaceutical drug product development leader with over 25 years of experience in formulation, drug product, and process development across biologics and complex modalities. She has a proven track record navigating national and international regulatory landscapes to deliver clinical and commercial quality medicines. Myrna is known for building and implementing effective development processes, leading global cross-functional teams, and serving as a technical coach and mentor with a strong execution focus.

Core Expertise

  • Drug Product Development
  • Biopharmaceutical Formulation & Process Development
  • CMC Strategy & Regulatory Filings
  • Technology Transfer & CDMO Management
  • Aseptic Processing & Device Integration

Career Highlights

  • Director, Strategic External Development: Led drug product development for 10+ early- and late-stage assets; delivered emergency-use biologics under accelerated timelines; conducted technical due diligence, managed deviations and CAPAs, selected CDMO partners, and supported global regulatory submissions.

  • Director, Biopharm Product Development: Directed CMC teams for multiple biologic products, including device integration and shelf-life studies; authored BLA and MAA sections; led robotic sterile filler initiatives and advanced ADC stability comparability assessments.

  • Biopharm Product Development Leader: Led formulation and process development for monoclonal antibodies, bispecifics, and novel biologic formats; oversaw global launches across 40+ markets; developed subcutaneous delivery strategies and supported regulatory interactions with FDA, EMA, PMDA, Health Canada, and other agencies.

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