Job description

Roles and Responsibilities
Department: Biosimilar-MSAT (Downstream and Upstream)
Experience: 10-15 years
Qualification: BTech/ MTech/ MSc
To manage MSAT Lab functions on routine basis for downstream and upstream related activities
Technology transfer with CMO
Good Process knowledge
To ensure product life cycle management
To handle continuous verification of process, deviation and out of specifications
Ensure laboratory records are in complaint with the SOPs
To follow up with the process teams on the experiments needs to be conducted as part of root
cause investigations
To evaluate the alternate vendors for critical raw materials and consumables as required
To perform lab scale experiments as part of resin shelf life studies
Authoring/ review protocol and technical reports to support process changes, modifications, improvements and scale up to support implementation at manufacturing scale. Authoring study protocols and reports for any trials to support the same.
Contribute at team discussions of CMC and other decision-making forums for development, clinical and commercial manufacturing.
Experience with Microbial products is preferable. Upstream candidate should have handled Microbial fermentation


Clinical Research Manager
Pharma, Biotech, Clinical Research
Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Full Time, Permanent
R&D
Education
B.Tech/B.E. in Any Specialization
MS/M.Sc(Science) in Any Specialization, M.Tech in Any Specialization
Ph.D in Any Specialization
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