R&D Downstream Processing Team Lead - Insulins

Why Join Biocon Biologics?

Join a world-class biologics organization where innovation, science, and impact come together. At Biocon Biologics, you will have the opportunity to lead cutting-edge biologics development programs, collaborate with global experts, and contribute to making affordable, high-quality biologic therapies accessible to patients worldwide.

About the Role

We are seeking an experienced and passionate Team Lead - Downstream Process Development to drive the development and optimization of purification processes for monoclonal antibodies and other biologics across the product lifecycle. The ideal candidate combines strong scientific leadership with hands-on expertise in chromatography, filtration, process characterization, and regulatory-compliant biologics development.

Role & responsibilities :

• Lead downstream process development of biologics (early phase till late phase development), especially monoclonal antibodies and Insulins.
• Lead group of scientists/Interns.
• Serve as a technical resource and leader for the project team through having in-depth knowledge and experience in purification process development.
• Work collaboratively and cross-functionally with other teams (pilot plant, analytics, MSAT, QA, regulatory and production) to meet team and company goals (process development, technology transfer and scale up, risk assessment, process characterization, etc).
• Planning/execution of experiments using DoE approach, for process development, process characterization and process improvement of DSP operations (Chromatography and Filtration).
• Risk analysis of downstream process unit operations, scale down studies and process validation support for manufacturing operations, support life cycle management of approved programs and support investigations related to manufacturing OOS and deviations.
• Compilation, Trending and evaluation of data with Statistical tools/software.
• Comparative data evaluation with Manufacturing scale batches to define ranges and specifications.
• Understand and adhere to corporate standards regarding code of conduct, documentation, safety, appropriate handling of materials, and GxP compliance .
• Demonstrate the ability to resolve key project hurdles independently by effectively utilizing available information and technical expertise. Resolve to meet project timelines despite challenges.

You would be a fit if you hold:

• a Masters degree MTech/MSc in Bioprocess engineering/technology or any life sciences with 8-12 Years of industry experience
• a PhD in similar fields with 2-3 Years of industry experience.

Biocon Biologics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status. Biocon Biologics also complies with all applicable national, state and local laws governing non-discrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act.