Novartis In Vitro Manager Job Opening – Apply Online
Pharmaceutical Jobs. Applications are invited for the post of IVIVC (In Vitro In Vivo Correlation) Manager- [email protected] Novartis.Career @ Novartis. Pharma job opportunity at Novartis.vacancy at Novartis. Interested candidates may apply online. Check out all the details on Rasayanika.com
Job Title: IVIVC (In Vitro In Vivo Correlation) Manager- Respiratory
MSc/ M. Pharm/ PhD (Pharmacy or Life science) with fluent in English (oral and written)
• 6 years of experience in IVIVC for respiratory drug products
• Knowledge of pharmacy, pharmacokinetics, pharmacodynamics statistics and/or clinical trials
• Should have sound knowledge in WinNonlin, GastroPlus, and IVIVC tools. Solid knowledge of GCP and worldwide regulatory requirements related to assigned area
• Solid medical/scientific writing skills; Computer literacy. Ability to analyze, discuss, interpret and present scientific data
• Excellent communication skills and cross-cultural awareness, able to efficiently collaborate with experts across different sites and geographies.
Your responsibilities include, but are not limited to:
•Responsible for chipping in and driving the clinical development strategy for respiratory drug products in close collaboration with the development and project teams. Responsible for review and update of the clinical development strategy as needed.
•Give good cross-functional understanding and experience of generic inhaler development and device technology to the project team. Responsible to work closely with technical development to link technical and clinical expertise.
•Be familiar with characteristics of API, excipients and have an understanding which parameters are affecting bioavailability; Preparation of bioequivalence risk assessment from literature data and in-vitro data
•Sound understanding of the challenges of the product and product development, e.g. influence of priming, determinant of in vitro variability between batches, particle size.
•Able to analyze and interpret in vitro study results and dossiers. Must have fair knowledge of in-vitro and in-vivo correlation and device mechanisms of orally inhaled products.
•Validated skills and abilities in quantifying in vitro determinants influencing in vivo exposures of orally inhaled products and in batch selection.
•Should have sound knowledge of application of tools like Win-Nonlin, Gastro-Plus, and IVIVC toolkit.
•Experience with different study types (e.g. pharmacokinetic studies, therapeutic endpoint studies and scintigraphy studies (preferable).
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