Scientist (Protein analysis and characterization)

 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 new 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)
• Good 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 good 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 guidelines.
• Data evaluation with statistics and analytical thinking.
• Good documentation practices using MS office.
• Good oral and written communication. 

 

. Skillset Required: Chromatography-based analysis, Method development, Method qualification, Method transfer, ICH/USP/EP/IP guidelines, Protocol writing, Report writing, Cross-functional coordination, Product specifications, GMP coordination, Stability studies, Lab documentation (SOP, STP, COA, MOA, Specification), Data interpretation, Regulatory submissions, Analytical data review, HPLC, U(H)PLC, CE-based analysis, Glycan analysis, Sialic acid content analysis, SOLO VPE, UV-Vis Spectrophotometer, Good laboratory practices, Data integrity, Good documentation practices, Statistics, Analytical thinking, MS Office, Oral communication, Written communication, Protein characterization, Recombinant proteins, Antibody characterization, Biosimilars characterization, Recombinant hormones