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ASSOCIATE SCIENTIFIC MANAGER I
Biocon Biologics Limitedindia, India1 day ago
Job descriptionFunctional lead for downstream operations for Biosmilars Planning designing and execution of experiments for process characterization, of DSP operations (Chromatography, reaction, freeze drying, Filtration). Co-ordination for CMC related issues with advanced and Emergin markets requirements, Desiging study protocols and reports for regulatory submissions. Scale down studies, process characterization, process validation and resin re-usability support for manufacturing operations . Risk analysis for DSP process and defining the ranges (MOR and PAR). Compilation, Trending and Statistical analysis of experimental data for evaluation. Comparative data evaluation with Manufacturing batches to define ranges. Manage personal time and resources to realise high performance team Effectively communicate the project updates and timelines Manage and retain critical talents, realizing low attrition and coordinate hiring in case of replacement / expanding teams Process development, process characterization / Validation knowledge and experience, designing study for regulatory support / dossier filing in advanced and emerging markets. Knowledge of DSP and manufacturing operations, trouble shooting, Risk assessment, DoE, Statistical analysis of process data, Regulatory challenges Guiding reportees technically and managing their deliverables Plan and co-ordinate with other cross functional teams Effective communication and presentation skills, excellent technical writing Functional lead for downstream operations for Biosmilars Planning designing and execution of experiments for process characterization, of DSP operations (Chromatography, reaction, freeze drying, Filtration). Co-ordination for CMC related issues with advanced and Emergin markets requirements, Desiging study protocols and reports for regulatory submissions. Scale down studies, process characterization, process validation and resin re-usability support for manufacturing operations . Risk analysis for DSP process and defining the ranges (MOR and PAR). Compilation, Trending and Statistical analysis of experimental data for evaluation. Comparative data evaluation with Manufacturing batches to define ranges. Manage personal time and resources to realise high performance team Effectively communicate the project updates and timelines Manage and retain critical talents, realizing low attrition and coordinate hiring in case of replacement / expanding teams
Department Details
Role Summary
Technical / functional skills
- Process development, process characterization / Validation knowledge and experience, designing study for regulatory support / dossier filing in advanced and emerging markets.
- Knowledge of DSP and manufacturing operations, trouble shooting, Risk assessment, DoE, Statistical analysis of process data, Regulatory challenges
- Guiding reportees technically and managing their deliverables
- Plan and co-ordinate with other cross functional teams
- Effective communication and presentation skills, excellent technical writing
Key responsibilities
Key Responsibilities
Technical / functional skills
Key responsibilities
Educational Qualifications
Required Education Qualification :
Required Experience : 9 - 12 years
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Associate Manager • india, India
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