Manager/ Sr. Manager Formulation Development Umedica Laboratories Private Limited

8.0 - 12.0 years

0 Lacs

navi mumbai, maharashtra

On-site

UMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations including Injectables, Tablets, Capsules, Suspensions, Dry Syrups, etc. Our manufacturing facility, situated in Vapi (Gujarat), holds approval from global regulatory authorities. Founded in 1983, UMEDICA operates in over 85 countries across the globe, encompassing EU, UK, USA, Canada, Australia, Middle East, Central & South American countries, Africa, Asia & CIS countries. Upholding a culture of innovation & continuous improvement, we at UMEDICA constantly strive for excellence. We are currently looking for a dynamic and experienced Manager/ Sr. Manager specializing in Formulation Development for Oral Liquid products to join our R&D Centre located at Turbe. This role will directly report to the GM Formulation Development. The remuneration package will be competitive and aligned with the candidate's professional experience and prevailing market standards. Key Responsibilities: - Minimum 8 years of experience in formulating and developing oral liquid dosage forms compliant with US & EU regulations. - Actively involved in the development of liquid products, including excipient identification, prototype formulation based on innovator product characterization, and selection of primary packaging components. - Proficient in initiating stability batches and generating necessary GxP documentation. - Thorough understanding of scale-up and EB manufacturing processes. - Independent preparation of formulation development documents such as development reports, MFC, specifications, and tech transfer documents. - Support in addressing regulatory queries for the US & EU markets. - In-depth knowledge of excipients, their functions, and applications. Other responsibilities: - Execution of product development activities in adherence to GMP requirements. - Assistance in scale-up and EB batch operations. - Maintenance of laboratory environment as per GXP requirements, formulation of SOPs, and system development. - Comprehensive understanding of regulatory agency prerequisites. - Independent handling of plant operations. Required Skills & Competencies: - Expertise in Oral Liquid formulation. - Strong grasp of regulatory stipulations from FDA, EMA, ICH guidelines, QbD, and BCS-based biowaivers. - Knowledge of intellectual property considerations in formulation design such as FTF and PIV. - Hands-on experience with formulation equipment and scale-up processes including granulators, compression, encapsulation, and coating. - Proficiency in data interpretation, scientific writing, and regulatory documentation. Qualifications & Experience: - M.Pharm in Pharmaceutics, Pharmaceutical Sciences, or related field. - 8 to 12 years of experience in the formulation development of oral liquid dosage forms. - Demonstrated success in technology transfer, global regulatory filings, and team leadership.,

Posted 3 weeks ago

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