Job Description

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:

• 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

Educational Qualifications
Required Education Qualification: M.Sc
Required Experience: 9 - 12 years

Skills Required