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 robust fit for this role if you have:

- Hold a Ph.D. (Bioprocess or Biotechnology or Chemical Engineering) with 1- 3 years of industrial experience or
- M. Tech (Bioprocess or Biotechnology or Chemical Engineering) with at least 7 - 10 years of experience in downstream process development.

We are an equal opportunity employer and are committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, age, marital status, disability, veteran status, or any other status protected by applicable laws.

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