Personal information
Biography
EXPERIENCE SUMMARY
I offer 16+ years of progressive leadership in parenteral biologics and gene therapy platforms (process development, scale up, technology transfer to commercial scale manufacturing).
ABOUT Me
I am a highly motivated and focused leader in the biopharmaceutical MSAT (Clinical & commercial) and late stage Process Development (PD) with through understanding of MSAT and PD support for biological product’s life cycle management. I have a detail technical understanding of processes and can also lead teams, focusing to deliver projects right at first time and on time. Skilled in building motivated teams and make strategic change for improvement.
AREA OF EXPERTISE
• Leading process development, scale up, tech transfer and Manufacturing support functions with strong record of trouble shooting productivity and product quality issues at manufacturing scale.
• Excelled in leading process characterization Studies using Quality by design tools like FMEA and DOE as recommended by ICH Q8(R2)
• Experienced with both suspension (NSO, CHO) and adherent (HEK293) cell lines.
• Excelled in managing Stage 3 Process validation - Continues Process Verification (CPV) program.