Job Title: Asst. Manager - MSAT
Purpose of Job
Supporting MSAT DSP functions
Skill Required
Well versed with DSP operations for biopharmaceuticals both from microbial and cell culture products including drug conjugates and Scale up
Knowledge on Technology transfer for Inhouse and in-licensing projects with clear understanding of requirements and documentation
Risk assessment for process characterization and statistical analysis
Well versed of process monitoring with different statistical tools
Knowledge on Extractable and leachable assessment for product contact parts based on guidelines
Roles and Responsibilites
Plan and strategize the execution for purification process for process improvement
Working closely with manufacturing team for the support required onsite technology transfer, facility fit and related document preparation for process validation
Handling the process deviations and root cause analysis with proper CAPA implementation
Working in coordination with manufacturing to complete the at scale batches, process validation campaign and documentation
Planning for the execution of supportive studies (Hold time protocols and reports, resin and membrane reuse verification) required as a part of process validation
Responsible for risk assessment and execution of Process characterization studies for DSP operations
Evaluation of alternate strategy to reduce the cost of process
Qualification Required
Msc/ M.Tech in Biotechnology /Bioprocess technology
Relevant skills / Industry experience
6-8 years of experience in the DSP (MSAT /R&D/ Production)
Biotech, Ahmedabad, GJ, IN, 382213