MSc Biotech, Biochem Scientist Role at Bharat Serums and Vaccines (BSV)

• The candidate will function as a part of the analytical development team responsible for analytical evaluation of biosimilars at various stages of product development.
• Thorough knowledge of HPLC based analysis of recombinant proteins. Viz. RP-HPLC, SE-HPLC, glycan analysis etc.
• Independently design method development of proteins, qualification, 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 working in co- ordination with the Cell culture and downstream teams in Biotech R&D.
• Set-up product related test/ release specifications and analytical protocols Biotech products.
• Design inhouse /outsource methods for Physico-chemical characterization of biological products.
• Co-ordination with QC for smooth implementation of new methods.
• Maintenance of equipment logs and documentation in the lab.
• Maintaining and monitoring stability 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 of analytical data for in-process & stability related activities.

Accountabilities and Responsibilities:

• Responsible for various development activities related to HPLC/UHPLC and other analytical/UHPLC
• Ensure data integrity and good documentation practices.

Competencies:

• Knowledge and hands-on experience of carrying out HPLC/UHPLC method developments and qualifications on biosimilars/ recombinant proteins.
• Good documentation practices.
• Fluency in using MS office.
• Expected to be good at oral and written communication, as the position would require cross-functional interactions with co-functional teams like process team, QC.
• Analytical thinking.