Formulation Scientist

The role is to be lead the design and development of complex injectable emulsion, suspensions and solutions for parenteral and ophthalmic dosage forms, oversees pr-formulation studies, lead the scale-up & technology transfer, troubleshoot complex formulation and processing issues.• People management, proper planning and delegation of work, and motivation of team members• Mentor team members in product development, tech transfer and scientific documentation• Need eye for detail, excellent capability to review work allotted to team members to ensure right first time approach towards product development and quality documentation• Identify development needs of team members and ensure appropriate and timely feedback is provided to them• Proven track record of successful product development from start to filing and approval of drug products with focus on injectables in regulated markets and ROW• Expertise in process optimization, scale-up, provide technical support for manufacturing and troubleshooting of commercial products• Enable regular project tracking by communication with related departments like project management, business development, analytical department, RA, IPR, QA, Store, Purchase, manufacturing site.• Address post submission queries of different regulatory agencies• Knowledge of QbD based product development• Preparation and review of R&D documents (MFR, BMR, TTD, PDR) for regulatory submission. Preparation of SOP & implementation.• Sound knowledge of use of PAT Tools in product development• Evaluation of machinery vendors and FAT•Evaluation of project feasibility in terms of technical, IPR, regulatory and costing considerations in coordination with cross functional departments• Well versed with Microsoft Office tools, DOE softwareProfile:•Strong interpersonal skills – able to work effectively with operational staff in the manufacturing site and project management.•Knowledge of technology transfer and GMP pharmaceutical processes and scale-up and guidelines/regulations.•Fluent in English and local language with good communication skills.•Candidate should have exposure of Formulation development of injectable, Knowledge of regulatory market required.Location:Ambernath, Boisar

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