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