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This role involves receiving and understanding technology from the FnD department. · ...
Gandhinagar1 month ago
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The role involves supporting the analytical lifecycle of biosimilar products in the MSAT-ADL laboratory. · Develop and validate analytical methods for biologics, biosimilars, and upstream processing. · Transfer methods from research to manufacturing scale-up. · ...
Ahmedabad1 week ago
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We are seeking an Executive - MSAT (ADL) to work in our MSAT-ADL team. The successful candidate will provide analytical support in method development, method qualification, and process testing during scale-up and global development. · We offer a dynamic environment that fosters c ...
Daskroi1 day ago
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To work in MSAT-ADL team and provide analytical support in method development, method qualification, in process/DS testing during scale-up, global development and technology transfer throughout product life cycle. · We believe that when diverse skills and perspectives unite under ...
Daskroi ₹900,000 - ₹2,200,000 (INR) per year1 day ago
Executive- Formulation tech transfer/PDL/ MSAT - Gandhinagar - confidential
Description
Job description
Role & responsibilities
• To receive and understand the technology from FnD dept.
• To design optimisation for process parameters & participate in the trials at R&D.
• To transfer the technology from R&D to receivers site for the respective product.
• To monitor the TT demo / exhibit/scale up and optimization batches.
• To review the technical information sheet, product detail, raw material/accessories/ equipment requirement for plant trial/SU/Exhibit batches.
• To propose and fix the batch size i.e. of the Demo, Scale up, Exhibit and Commercial based on Equipment Capacity/Qualification, Scale Up factor calculations & annual requirements.
• To get involved and observe in the TT demo batch with F&D.
• To take scale up batch at manufacturing locations and prepare scale up batch protocol, Scale Up Reports, MFC, Sampling Protocol, Risk Assessment etc.
• To take the exhibit batches at the manufacturing locations and take care for its trouble shooting.
• To prepare the summary reports.
• To perform investigation for Deviation/ OOS/ OOT observed during SU/EB at plant. To prepare agency query responses.
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