Team Lead - R&D; Downstream Processing
Bangalore, IN

Role in a nutshell :

Team Lead for the development, characterization, validation, and regulatory support of downstream purification processes for biosimilars, while managing a technical team, driving process robustness and manufacturing support, ensuring regulatory compliance, and collaborating cross-functionally to deliver high-quality biologics products.

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 :

Team 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

You are a solid fit for this role if you ha

📌 Downstream Processing Team Lead (Bengaluru)
🏢 BIOCON BIOLOGICS
📍 Bengaluru