Piramal - Senior Group Leader - Formulations - Parenteral Products Development - USA & Europe Market

Industry - Pharmaceuticals

Skills - Injectable, Formulation

Job Type - Permanent

Description - Leading parenteral formulation team : Type of dosages are includes but not limited simple injection, lyophilized product, liposome, Nano & micro suspension, ophthalmic, topical solution & gel, NCE Nano formulation for preclinical support.

- Leading Preformulation group - Solubility determination, Dissociation (PKa) profile determination, salt screening, polymorphism etc.

- Developing simple and complex Ready-To-Use (R-T-U) injections, aqueous and non-aqueous based lyophilized product and sterile injectable suspensions for regulatory market from strategy preparation, tech transfer to NDA, ANDA filling support

- Hands on experience on liposomes product development for generic and NCE molecules. Strong knowledge on development and characterization of liposomes or vesicular (polymersomes) and micellar drug delivery system.

- Ensure lab compliance with GMP/GLP and safety requirements

- Interacting with clients, meeting timeline and providing solutions to problem/challenges faced

- Responsible for technology transfer all formulation projects from development to GMP manufacturing sites

- Ensuring all activities are conducted with quality system in mind. Ensuring data integrity and traceability of all data generate.

- Responsible for planning and managing departmental budget and project costing

- Demonstrate strong leadership and management skills with strong scientific rigor in the group and within cross functional project teams. Cross functional collaborations within Research and Development in the different departments, plant sites to accomplish Company goals

- Experience in and responsibility of supervising and developing junior/mid-level scientists forms an important aspect of this role

- M.Pharma (Pharmaceutics) & Ph.D (Post Doc preferred but not mandatory) with 8-10 years experience in complex parenteral products development for regulated market mainly USA and Europe

Contact - Ekta Chhoda

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