Website Stelis BioPharma Pvt Ltd.

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.


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