Bharat Serums and Vaccines Limited is a leading biopharma company focusing on women’s health, fertility, critical care and emergency medicine. We are a Mankind Pharma Limited Group Company. Mankind Pharma is ranked among the top 3 pharma companies in India. Mankind Pharma has a base multi-speciality therapy business, consumer healthcare business and speciality business, BSV is the super speciality business run as an independent group company. BSV’s focused therapy areas such as women’s health & fertility, for example, makes us one of the only few biopharma companies that manufacturers complex and niche biosimilars, making us a super speciality business.
About the Role
This role provides an chance to learn and grow as an expert in the field of antibody (m Abs), recombinant hormones and protein biosimilars characterization and analytical R&D; for therapeutic proteins.
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.
Qualifications
Masters in science (Biotechnology/Biochemistry) with 7 to 9 years of experience
M. Tech in Biotechnology
Masters in Pharmaceutical (Biotechnology)
Required Skills:
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