About Client: leading Indian biopharmaceutical company, specializing in high-barrier biologicals, biosimilars, and injectables
Job Summary : This role provides an opportunity to learn and grow as an expert in the field of antibody (mAbs), recombinant hormones and protein biosimilars characterization and analytical R&D; for therapeutic proteins.
Key Responsibilities:
- Thorough knowledge of chromatography-based analysis of recombinant and highly glycosylated proteins.
- Independently design method development of proteins, method qualification, method transfer following ICH/USP/EP/IP guidelines, including the writing and review of protocols, transfer plans, and reports.
- Carry out day-to-day analytical work and work in co-ordination with cross-functional teams in Biotech R&D.;
- Thorough knowledge on setting up product related specifications.
- Co-ordination with GMP facility for smooth implementation of recent methods.
- Maintaining and monitoring stability studies of various products in Biotech.
- Responsible for preparation of lab related documents,



regulatory submission documents and QC supports (SOP, STP, COA, MOA, Specification).
- Interpret data and write reports in support of regulatory submissions.
- Reviewing analytical data for in-process & stability related activities.

Qualification & Expertise:
- Masters in science/M. Tech/Masters in Pharmaceutical (Biotechnology/Biochemistry)
- Positive knowledge and understanding of proteins. Sound knowledge on good laboratory practices. Hands-on experience on HPLC /U(H)PLC and CE based analysis for protein and/or peptide is preferred
- Responsible for chromatography-based analysis of R&D; project/process samples.
- Provide characterization/analytical support to process/internal teams as and when required.
- Ensure data integrity and positive documentation practices.
- Expertise in Glycan, Sialic acid content analysis.
- Hands on experience on SOLO VPE, UV-Vis Spectrophotometer.
- Sound knowledge on ICH and other analytical guideli

📌 Scientist (Protein analysis and characterization) (Mumbai)
🏢 Talental Consultings
📍 Mumbai