Senior Executive – Biopharmaceutics

Job Description:

Responsibilities 

• Work with product development, clinical, regulatory and any other cross-functional teams to support product innovation and development
• Provide inputs to formulation and analytical teams to identify product specific Bio-relevant/Bio-discriminatory media
• Identify in-vitro characterization tools and methodologies relevant to the in-vivo behavior of the formulations to select appropriate formulation strategies
• Evaluate data from biostudies to identify critical parameters (CMA, CFC, CPP) to enhance success in bioequivalence studies
• Perform mechanistic Modelling & Simulation to simulate the in vitro dissolution of active pharmaceutical ingredients (API) and formulation excipients under various experimental conditions and predict the in vivo pharmacokinetic profile
• Build and validate IVIVC/IVIVR for products when feasible
• Monitor and plan external development activities as required
• Search, compile and interpret scientific data, write reports, regulatory documents, manuscripts, and present work at internal and/or external meetings

Qualification & Expeirence

• Masters in Pharmaceutical Science or a post-graduate degree in a related scientific discipline with a 7+ years’ relevant experience in the pharmaceutical industry.