Stelis Biopharma
Location
Bangalore | India
Job description
Roles & Responsibilities:
Well-versed in aseptic handling techniques, handling day-to-day activities of the upstream process (Autoclaving, STR, and wave Bioreactor setup, Calibration of instruments, Lab record maintenance)
Highly proficient in planning and executing projects to meet the project timeline.
Experienced in handling mammalian cell suspension and adherent cell lines.
Cell culture Process development for mAbs, Fusion molecules, and Glycoproteins, optimization and Process characterization of an upstream process for biosimilar molecules
Prior experience in leading a team of cell culture scientists and developing cell culture processes for mAb and glycoproteins. (6-8 people)
Knowledgeable and execution expertise in AMBR, DOE-based development, Scale-up, and Scale-down of processes.
Hands-on experience in media preparation, vial thawing, culture passaging, etc.
Experienced in handling process execution at shake flask to 50L scale.
Handling of equipment- Vicell analyzer, BGA, CEDEX, AMBR, Microscope, Wave bioreactor, AMBR, STR, etc.
Handling of single-use bioreactors and assemblies (up to 2KL)
Data collation and data presentation, data analysis using data analytics software (Minitab, JMP, etc.)
Planning and execution of Consistency batches.
Support to tech transfer activities from lab scale to 2KL Scale or higher.
Knowledgeable and execution expertise in process optimization (feeding strategy development for titer improvement, charge variant, and glycan).
Troubleshooting of deviations and challenges in process parameters.
Preparation of documents (Process development reports, consistency reports, etc), handling of deviations, root cause investigation, and CAPA and other relevant documents.
Experience & Education:
M.Sc./ M.Pharma with 10 years of relevant experience in Upstream Process Development.
Job tags
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