Scientist- Peptide Characterization - Hyderabad, India - Eugia Pharma Specialities Ltd

Description

We are looking for Peptide characterization Analytical Scientist with 10-15 years experience.

Qualification: M. pharmacy/ M.Sc

1. Experience in Biophysical characterization of Synthetic peptides and complex generics.
2. Good experience in operating, trouble shotting and conducting projects independently on CD, FTIR, SEC-MALS, AUC, DLS, Zetasizer, HPLC etc for conducting secondary structure analysis, Aggregation/oligomerization, related substances of Peptides/Proteins.
3. Experience on analytical and characterization of Peptide formulations as per "ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin" guidelines.
4. Method development, validation and batch analysis of analytical and characterization experiments pertaining to injectable, lyophilized, depot, and complex formulations.
5. Data review of analytical and characterization experiments, preparation/review of summary reports, SOPs, Protocols and Reports.
6. To provide technical support to QCs on methods and materials.
7. To support regulatory department in filings, addressing deficiencies and providing justifications.
8. Training the scientists, ensuring effective teamwork and individual growth.
9. Knowledge of current guidance documents issued by regulatory agencies.