HEAD - Formulation Research & Development (injectables) at Hyderabad
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Responsible for ideation, review of literature, Patent search, conceptualization, strategization, experimental designing and supervision of entire developmental activities for all Regulated markets.
Supervising the development of new product development (Parenterals) by complying GLP procedures and ICH guidelines.
Planning for scale-up and optimization of manufacturing process; pre-exhibit and exhibit batches; scale up and technology transfer from RD to production to meet established project goals and timelines.
Familiarity with QBD project management methodology, demonstrated ability to lead project teams and scientists.
Plan and contribute to project-related scientific/technical activities as per current FDA/EU requirement.
Writes protocols or propose specifications based on USP, ICH or other compendial or regulatory requirements.
Understanding and support to design Bio studies to justify bio equivalence between generic and R&D formulation where ever applicable.
Review of technical documents including product development report, quality overall summary and other relevant documents for regulatory filing purpose.
Review of LNBs, stability protocol, stability report, process validation protocol, process validation report, investigation reports, process characterization reports, process optimization protocol, process optimization reports and relevant departmental documents.
Review of SOPs, as well as review appropriate documentation, test results for accuracy, completeness and compliance with SOPs/GMP requirement.
Guiding and assigning the team to perform various lab batches, optimization batches, scale up batches and existing commercial batches for troubleshoots.
Selecting potential vendor for API and Excipients with respect to quality and cost effectiveness.
Interaction with CROs and CMOs as needed.
Coordinate with Regulatory affairs team for filing dossiers and addressing deficiencies; provide relevant documents to Regulatory Affairs in a timely manner for dossiers filings, amendments, supplements filing.