Sheetal Dobhal

• Created custom mappings across the patient sample life cycle as per SDTM standards.
• Data analysis and relationship derivation from multiple sources like EDC (Medidata), LIMS, and Laboratory Biomarker data.
• Mentored junior consultants, helping them enhance their skills and contribute more effectively to projects.
• Built strong relationships with clients through consistent communication and proactive problem-solving efforts.
• Collaborated with technical teams and dashboard to develop customized solutions that addressed unique client needs.

• Leading Bioanalytical team for clinical sample analysis.
• Clinical sample management (Sample receipt and reviewing sample tracker).
• Handling QMS activities.
• Auditing CROs like Covance and Celerion as sponsor's SME for bioanalytical work delegation.
• Review of clinical documents.

Achievement:

Qualified bioanalytical lab at Enzene Biosciences in 2021 and post that submitted bioanalytical reports to DCGI for two large molecules from the in house lab.

• Development of immunoassays for various biomolecules.
• Successful transfer and validation of immunoassays in the CRO laboratory as per FDA guidelines.
• Imparting trainings to the freshers on bioanalytical techniques.

Achievement:

Introduced bioanalytical work at Enzene bioscience Ltd and transferred various immunoassays to the CRO.

• Bioassay development and qualification for assessment of the relative potency of Biosimilars in compliance with USP guidelines.
• ELISA method development and qualification for assessment of the relative potency of Biosimilars in compliance with USP guidelines.
• Developed equivalence margins using PLA software for potency assay.
• Statistical analysis of data using PLA 2.0 and PLA 3.0.
• Data compilation and Preparation of MDR, MOA and MQR.
• Potency determination for Stability samples and In process samples.

Achievement: Awarded "BRAVO" for successfully developing and qualifying cell based potency assay.

• In-vitro screening of small molecules for anti-cancer activity assessment for multiple clients.
• Conducted pre clinical in vitro bioassays for various therapeutic areas viz, Oncology, Dermatology, Allergy and Metabolic disorders.
• Conducted GLP based safety studies viz,
  - HET-CAM (Hen’s Egg Test – Chorioallantoic membrane) assay for ocular irritation potential according to
  ICCVAM test method.
  - In vitro Phototoxicity test according to OECD guideline 432.
• Timely conduct of studies with proper documentation and archival for the multiple clients.
• Extensive and comprehensive scientific inputs
• Designing strategies and assessment of feasibility for new projects from the clients.
• Supervise maintenance of lab equipments.

Completed project "Determination of Cytotoxic and Apoptotic potential of therapeutic drugs on Prostate Cancer Cells (LnCap and Bph-1 cell lines)."