Sameer Pasha
Research Scientist (Senior Analyst), MSc-Biochemistry| Biologics | Biosimilars | Vaccines |Large Molecules | ELISA | Regulated Bioanalysis | GLP/GCLP | Lean Six Sigma-Green Belt | ISO-17025 |
- Role
- Analytical Writer at ICON plc
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Sameer Pasha
Through the tenure of over 8 years, I have evolved as a Senior Scientist with excellence…
Experience
Analytical Writer
May 2025 — Present · Bengaluru, IN
As an analytical writer I am responsible for writing reports of clinical or non-clinical studies performed in the Bio analytical Laboratories of ICON, according to international guidelines, regulatory and client requirements, delivering high quality and timely scientific, strategic and operational support for GLP, non-GLP and clinical studies.• Write Bioanalytical Method Development, Method Validation and Study Sample Analysis reports through assembly of data from various sources using various immunoanalytical techniques like PK/PD/ADA/NAb, LC-MS/MS, HPLC, Flow Cytometry etc• Communicate with responsible Project Managers and Bioanalytical Team Lead about lab results and conclusions to be reported.• Review of Bioanalytical Method Development, Method Validation and Study Sample Analysis reports for variousimmunoanalytical methods like-PK/PD/ADA/NAb, LC-MS/MS, HPLC, Flow Cytometry etc and processing of review comments from internal and external reviewers.• Create and modify templates, assist Project Managers by writing study documentation.• Upon complete review process (Analytical writer, LAB, BTL, PM, QA, Sponsor) finalize reports according to eCTD (pdf) requirements.
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