Scientist

Bharat Serums and Vaccines Limited

0 years

0 Lacs

navi mumbai maharashtra india

Posted:2 days ago| Platform:

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Skills Required

analysis design development ip writing reports qc maintenance documentation monitoring stability data support

Work Mode

On-site

Job Type

Full Time

Job Description

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.

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