FRD Injectable - Officer / Executive

Formulation Development of Complex, Lyophilized formulation, Oncology Injectable formulation for US, EU, UK, Domestic and ROW market.

Review Patent, literature and guidelines related to US, EU and UK market and make strategy for US, EU and UK market product approval.

Design and conduct Pre formulation study, Manufacturing Process development with development study, filter validation, Extractable and leachable study and Container Closure studies for New Formulation.

Apply scientific fundamentals to resolve formulation process query, Impurities query, pH query and stability problems in Injectable formulation and Injectable products.

Co-ordination with other departments including Analytical, Purchase, QA, Regulatory Affairs, Production and Project Management.