Company: BioGenomics Ltd
Department: Formulation
Post: principal scientist
Location: Thane
Requirements
- Master's in microbiology/Life science
- Experience of working with Insulin analogs
- Total Experience- 8 - 12 years
Key Responsibility areas
- Developing New formulations for protein therapeutics such as Insulin & Insulin analogs & improving the existing formulations
- Carrying out Stability Studies
- Analytical Method Development & Tech Transfer to Manufacturing Plant
- Characterization of Drug Product. \
- Preparing for various Audits, ensuring compliance & actively participating in conducting the audits. Support the formulation fill finish & product release requirements from Manufacturing.
- Lead the department to ensure that all internal and external customer expectations are met and department objectives are achieved.
- Report performance of team and individual members and organize necessary interventions for improvement.
Technical Competencies
- Pre-formulation & Formulation Method development & Validation for products such as Insulin & Insulin Analogs
- Knowledge of Chemistry & Analytical instruments like HPLC, LCMS and Bioassay Methods.
- Product Specific knowledge
- Thorough understanding of Regulatory Affairs, IPR & different guidelines like ICH (Schedule O, S, E & M), EMEA, FDA, Central Drugs Standard Control Organization (CDSCO).
- Exposure to Manufacturing of Protein Therapeutics.
Please share your resumes on Careers@biogenomics.co.in
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