Research Associate
2 - 5 yrs
Chennai
Job Description
- Responsibilities
- Strong technical expertise in protein analytical method, formulation development, biophysical characterization of protein aggregation and/or protein stability.
- A minimum of two years working experience with characterization of degradation mechanisms of proteins especially using chromatographic techniques and development of analytical methodologies for characterization of drug product attributes is required.
- Experience in formulation and/or fill/finish process development for biological drug products demonstrating interpretation of analytical data and writing reports is required.
- Strong working knowledge of size-exclusion and reverses phase HPLC, HIAC and or MFI particle characterization techniques is preferred.
- Experience with frozen liquid, liquid in vials or pre-filled syringe and lyophilization cycle development is preferred.
- Some working knowledge of GMP requirements, process analytical technologies (PAT) and Quality by design (QbD) is also preferred.
- Experience implementing and maintaining high quality standards for all aspects of work conducted including adherence to regulatory GLP/GMP, departmental, and safety guidelines is preferred
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