Manager - Biologics

Key Requirements:

• Hands on experience in Upstream, Downstream and Analytical processes
• Documents preparation and review at Development and technology stages
• Organized, self-motivated and capable of working independently or in a collaborative environment.
• Strong oral and written communication skills

Roles & Responsibilities:

• End to end delivery of Biosimilar projects starting from project initiation to commercialization.
• Hands on experience in Upstream, Downstream and Analytical processes
• Clone development and establishment (Selection to transformation)
• Execute and manage shake flask and bench scale bioreactor experiments.
• Hands on experience in optimization studies like Media Optimization, Yield Optimization and Reactor Process Optimization
• Supporting the team in the set-up, operation, and associated analysis of Bacterial & mammalian cell culture and bioreactor processes.
• General operations such as bioreactor building/sterilization.
• Sampling including cell count and metabolite analysis.
• Prepare solutions and culture media & Perform data analysis.
• Purification of the final proteins using different downstream purification techniques including column chromatography, precipitations, extractions, filtration techniques etc. with minimal guidance from superior.
• Working Experience in Chromatographic techniques like Akta Pure Affinity Chromatography, AEX, CEX, SEC, HIC, Multi-mode chromatography and De-salting Column.
• Experience in optimizing Affinity Tagg Removal, Buffer Optimization, Process optimization Studies.
• Working Experience in TFF for protein Separation, Removal of impurities at different stages of product development such as Host cell protein (HCPs), Host Cell DNA (HCD) in separation process
• Experience in ELISA reader for protein verification and concentration analysis
• Working knowledge in HPLC Techniques (Waters and Agilent Technology) - Quantification analysis of amino acids residues in feed and media and Protein-A HPLC-IgG in Clarified harvest.
• Experience in peptide analysis and mapping using RP-HPLC, SEC-HPLC and IEX-HPLC
• Working Experience in SDS PAGE-Ag Staining, GEL-Electrophoresis, PCR techniques, UV Spectroscopy
• Working Experience in FTIR for Impurities studies
• Guide a process development team on all downstream processing steps for microbial and mammalian cell culture.
• Protein-identification and characterization using different lab techniques.
• Stability testing of various protein products during product development.
• Collaborate and work with both the Upstream processing for a seamless process.
• Manage working with the transfer of technologies.
• Maintenance of the equipment and ordering chemicals on requirement.
• Thorough documentation in lab notebooks and preparation of SOPs, developmental reports etc.

Desired qualifications and skills:

• MSc/M.Tech in Biotechnology/Biochemistry/life science or equivalent with biotech/ pharma industry experience.
• 7 - 10 years of industry experience in Purification of recombinant proteins and downstream applications in bio-process technology.