Downstream Processing - Biologics @ Biocon Biologics

Job Description

Key responsibilities:

• Develop downstream process for biologics (recombinant monoclonal antibodies) from mammalian cell line especially CHO cell line.
• Plan and execute laboratory experiments for purification of biologics.
• Write and/or review process protocols, technical reports, risk assessment reports, technology transfer documents, process development reports, etc.
• 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, process characterization, etc).
• Planning/execution of experiments using DoE approach, for process development, process characterization and process improvement of DSP operations (Chromatography and Filtration).
• Mentor and guide junior scientists and interns.
• Risk analysis of downstream process unit operations, scale down studies and process validation support for manufacturing operations, support life cycle management of commercial programs and support investigations related to manufacturing OOS and deviations.
• Compilation, Trending and evaluation of data with Statistical tools/software (preferably JMP-SAS).
• Understand and adhere to corporate standards regarding code of conduct, documentation, safety, appropriate handling of materials, and GxP compliance.
• Complete project goals within timelines.

Experience:

• Ph.D with 3-5 years of experience OR
• MSc/MTech with 5-10 years of relevant experience in downstream processing of biologics (preferably monoclonal antibodies)

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Keyskills:   Chromatography Downstream Processing DSP Biosimilars Purification Filtration Column Chromatography Centrifugation Monoclonal Antibodies Fermentation Biologics Mammalian Cell Culture Extraction Downstream HPLC