Execute extensive physico-chemical characterization studies of proteins based on experimental design and plan documents, analyze the experimental findings within Biologics with the objective of: product characterization, establishing biosimilarity and identify impurities.
Education & Experience
MSc/ MTech/BTech (Biochemistry or Biotechnology), with 2-5 years’ experience Analytical Development of proteins
Good understanding of protein structures , biochemistry
Design of Experiment
- Drug testing for In-process samples, Batch release, Stability testing, Method Development & Method Validation.
- Working on Reverse Phase Chromatography, Size Exclusion Chromatography, Ion Exchange Chromatography, Peptide Mapping, Affinity-Chromatography, Protein estimation methods by HPLC & UPLC, etc
Execution of Experiment
- Analytical method transfer by using HPLC
- Qualification of Working Standards.
- Calibration of Analytical instruments like HPLC, UHPLC, pH Meter, Pipettes, Digital balance.
- TTD transfer (Technology Transfer) IRS Qualification, HPLC & UPLC Qualifications & Calibration, Column Management, Handling Reference Standards, & Documentation (i.e.) SOP, STP, Protocol & report preparations.
- Periodic capturing of the experimental data
- Basic understanding of Technical Report writing
- Documentation as per GMP practice
- Compile and analyze the experimental data in order to compare the structure, function and impurities between the in house and RMP.
Desired Skills & Competencies
- Competence with MS Office programs, particularly Word, Excel and PowerPoint
- Excellent learning ability
- Motivated and ready to explore new ideas
- Ability to communicate effectively with senior management as well as with peers
- Good verbal and written communication skills.