Scientist
2 weeks ago
**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.
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