Masters in science (Biotechnology/Biochemistry etc.) or,
Masters in Pharmaceutical Faculty (Biotechnology/Quality).
Good knowledge and understanding of proteins. Sound knowledge on good laboratory practices. Hands-on experience on HPLC /U(H)PLC and CE based analysis for protein and/or peptide is preferred.
Position Specific Requirements:
- 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 proto-cols, 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 Bio-tech 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.
- Ensure data integrity and good documentation practices.
Position Specific Skills:
- Experienced in analytical method development, validation, and transfer to GLP Facility
- Protein sample preparation techniques (Centrifugation/Concentration/Extraction etc.)
- Hands on common laboratory instruments UV-Vis Spectrometer meter, weighing balances.
- Sound knowledge on ICH and other analytical guidelines.
- Key Operations and troubleshooting of HPLC/U(H)PLC.
- Data evaluation with statistics and analytical thinking.
- Good documentation practices using MS office.
- Valuable oral and written communication.
📌 Sr Officer- Research Associate(ADL) || Pharma || Airoli -Navi Mumbai
🏢 Adecco India
📍 Navi Mumbai
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