Bharat Serums and Vaccines Limited (BSV) have used our scientific resources to develop a range of biological, biotech and pharmaceutical products. Today, as we influence patient outcomes in the therapeutic areas of Women’s health and Critical Care and IUI-IVF, we have the privilege of being a partner of choice.
Post : Scientist
Job Description
Key Responsibilities
• 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.
Candidate Profile
• MS/M.Sc(Science) in Biotechnology, Bio-Chemistry
• 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.
Additional Information
Experience : 6 to 10 year(s) of experience
Qualification : M.Sc
Location : Navi Mumbai,Maharashtra
Industry Type : Pharma / Healthcare / Clinical research
End Date : 5th July, 2023
See All Mumbai Alerts B.Pharm Alerts M.Pharm Alerts M.Sc Alerts
See All Other Jobs in our Database