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Scientist - F&D International - Injectables
About the job Scientist - F&D International - Injectables
Job Title: Scientist - F&D International - Injectables
Job Location: Navi Mumbai, Maharashtra, India
Job Location Type: On-site
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
- Literature Survey.
- Handle end to end responsibility of New Product development from conceptual stage to commercialization as per target timelines, planning, scheduling, monitoring and controlling of projects.
- Handling of Pilot plant, scale up studies, process development, process validation, batch size optimization, trouble shooting and site transfers.
- Responsible for setting up and stabilizing formulations process development laboratories and pilot plant.
- Designing, review and approval of master manufacturing, packaging documents (MFR, MPR), protocols, and technology transfer dossiers, product development reports, SOPs, Guidelines.
- Responsible for selection, design qualification, capacity attributes, handling feasibility, GMP aspects of various critical processing equipment namely laboratory Mill, lyophilizer, glass filtration assembly, laboratory balance, basket filter dryer, pharmasep filter and dryer laboratory stirrers, pH-conductivity meter, headspace oxygen meter, dissolved oxygen meter, powder filling machines, filtration assembly, homogenizer, peristaltic pumps, laboratory chillers etc.,
- Handling of machines installations, Validation (IQ, OQ, PQ) and develop vendors & upgrade them on latest market trends/ technologies.
- Addressing queries/deficiencies of various regulatory agencies and submit the responses within the stipulated time.
- To have close coordination with PMO, AD, PDL, DRA, CROs and other relevant service providers in all phases of the project life cycles.
- 10.To ensure optimal utilization of resources more particularly raw materials, plant and equipment capacities and yields
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