Manager Formulation Development and Research

Experience - 12 to 16 YearsQualification - M PharmResponsibilities Design and optimize manufacturing processes with technical improvements for regulated markets (US, Canada, EU) within allotted timelines. Evaluate manufacturing processes using DoE and QbD to define design space, control strategy, critical/ key parameters, and identify process risks.Screen manufacturing sites based on formulation and process complexity/feasibilityLead Technology transfer function with adequate project management skills to ensure successful scale-up of new products and effective launches with stipulated time. Define procedures for seamless product transfers between development and manufacturing (in-house and external), ensuring robust scale-up, accurate filings, and successful launches.Serve as SME for pharmaceutical processes and technologies, providing guidance in tech transfer, troubleshooting, and investigations to ensure robust performance and timely supply.Define and implement standards for formulation technology transfer and be the point contact for formulation technology transfer activities, with CFTs.Initiate, drive and facilitate capacity enhancement, cost reduction and time cycle reduction projects.Review and approve departmental SOPs to ensure compliance with cGMP and CQA guidelines, technical changes, change control, deviations and relevant documents. .Desired SkillsExpertise in formulation development of various dosage forms with strong knowledge of process optimization.Hands-on experience in technology transfer and scale-up Strong understanding of regulatory guidelines such as USFDA, EMA, WHO.Excellent documentation, communication, and analytical skillsAbility to work in a fast-paced, dynamic environmentProject management and cross-functional coordination

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