Irina Perdivara

About Irina Perdivara

Highly skilled industry professional, CMC and Quality Assurance Subject Matter Expert with demonstrated achievements in technical, compliance/quality and regulatory realms, and extensive GMP/cGMP experience in the development and commercialization of advanced biotherapeutics:• Highly adaptable and growth-oriented professional, ready to expand an extensive experience base into advanced biotherapeutics • Demonstrated ability to successfully transition between the technical/CMC domains and the quality/compliance domains, create and refine an efficient synergy of technical, compliance, and regulatory knowledge• People leadership: hiring, team building and performance management experience; passionate about developing staff to achieve both career goals and business milestones• Trained in Lean Six Sigma methodologies (yellow belt); critical/logical thinker; GEMBA-adept with a roll-up-the-sleeve attitude; proficient at problem solving and building consensus within cross-functional teams, leading to efficient investigations, root cause identifications, and effective CAPAs.• Thorough understanding of risk management principles as they apply to the API progression from clinical to commercial lifecycles, in addition to understanding of facility-related risks within the big picture of regulatory expectations• Technical Subject Matter Expert in the CMC space: analytical method lifecycle management, process transfer from small scale to GMP manufacturing, and process validation• Experienced with review of the CMC sections of customer regulatory filings • Subject Matter Expert in process validation, continuous process verification and quality batch record review and disposition• Highly accomplished at regulatory inspections readiness preparations, front room inspection hosting, story board creation, development of compliance strategies for defending customer projects• Subject Matter Expert in change management, risk management, deviations with a high degree of complexity, CAPA planning and execution, customer complaints, product surveillance notifications• Subject Matter Expert in SOP development and integrating them into the existing processes/SOP structure• Excellent technical writing skills, as evidenced by publication record, and number/quality of written/reviewed procedures, quality records, analytical methods, presentations, and reports authored in the various roles

Experience

1. Sr Manager Quality Assurance

   Heron Therapeutics, Inc

   Mar 2026 — Present

Education

• University of Konstanz

  Diploma (equiv. to M.Sc.), Chemistry

  2001 — 2006

• University of Konstanz

  Doctor of Philosophy (Ph.D.), Bioanalytical Chemistry

  2006 — 2009

Skills

• De Novo Sequencing
• Circular Dichroism
• Elisa
• Western Blotting
• Protein Purification
• Protein Structure Characterization by Mass Spectrometry
• 2d-Rp/Rp Uplc High/Low Ph
• Uv-Vis
• Lc-Ms/Ms
• Protein Chemistry
• Nano Uplc
• Proteomics: Sds-Page, Proteolytic Degradation, Mse
• Cid/Etd
• Site-Specific Glycosylation Profiling
• Nmr
• Mass Spectrometry
• Protein Glycosylation Analysis
• Characterization
• Biochemistry