Executive

1 week ago

Thane, India Rubicon Research Limited Full time

Responsible for formulation and process development of Oncology and hormonal products of oral dosage forms (Oral solid and Oral liquid formulations). Troubleshooting and problem-solving of unresolved or new formula issues. Design and execute formulation trials and evaluate stability data to finalize formulation composition. Develop manufacturing processes for R&D formulations so that the technical transfer is successful for large scale batches.Write/review master formulas, manufacturing procedures, SOPs, stability protocols/reports, process validation protocols/reports, Product Development Reports, QOS etc.Support the manufacturing of exhibit/submission batches per regulatory requirements. Support technology transfer for manufacturing processes from laboratory scale to production scale. Guide to junior team members for routine activities.Works with Analytical Development, Regulatory Affairs, Quality Control, Quality Assurance, Inventory Control, etc. to expedite the development and approval of new products by FDA. Assure that all formulation and process development activities are documented in the notebook as per company procedures and cGMPs. Requirements:Minimum Master’s Degree in Pharmaceutical sciences with 5+ years relevant experience. Candidate should have hands on/practical experience in development, technology transfer and ANDA submissions for solid/ liquid oral dosage forms (solutions, suspensions, tablet, capsules) for regulated and semi-regulated markets like US, Europe and ROW. Broad knowledge base of pharmaceutical sciences and processing in the Pharma industry

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