**Key Responsibilities**– 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.– Role:Pharmaceutical & Biotechnology – Other– Salary:Not Disclosed by Recruiter– Industry:Pharmaceutical & Life Sciences– Department:Research & Development– Role Category:Pharmaceutical & Biotechnology– Employment Type:Full Time, Permanent– Key Skills
Analytical
biosimilars
recombinant proteins
analysis
Method Development
GDP
MS Office
Skills highlighted with ‘‘ are preferred keyskills– Education– PG:MS/M.Sc(Science) in Biotechnology, Bio-Chemistry
Company Profile– Bharat Serums and Vaccines
**About BSV**:
– Our belief in Bringing Life to Life is anchored to a passion that has made us preserve, protect and enhance quality of life. For over four decades, we at BSV have used scientific resources to develop a range of biological, biotech and pharmaceutical products. Today, we have the privilege of working in close partnership with our customers and stakeholders to make a sustainable impact.- You are empowered to drive BSV’s vision:– We want to be a leading biopharmaceutical company driven by people and science to set benchmarks in patient outcomes across therapy areas of Womens Health, Critical Care and Emergency Medicine….