Scientist R & D (Analytical Development Laboratory-ADL)

About Client: leading Indian biopharmaceutical company specializing in high-barrier biologicals biosimilars and injectables

Department : R & D (Analytical Development Laboratory-ADL)

Role: Scientist (Protein analysis and characterization)

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:

• 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

Accountabilities and Responsibilities:

• 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.

Competencies:

• 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.