Primary Job Function :
The Manager Biopharmaceutics within Global Preclinical & Product Safety in Abbott Established Pharmaceutical Division (EPD) will provide scientific support in biopharmaceutics and pharmacokinetics to multi-disciplinary project teams for new product ideation, formulation development and biostudies that enable process and product development. The job collaborates with global/regional cross-functional teams to ensure adequate and timely support to all EPD Established Pharmaceutical projects.
Core Job Responsibilities:
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Work with product development, clinical, regulatory and any other cross-functional teams to support product innovation and development
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Provide inputs to formulation and analytical teams to identify product specific Bio-relevant/Bio-discriminatory media
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Identify in-vitro characterization tools and methodologies relevant to the in-vivo behavior of the formulations to select appropriate formulation strategies
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Evaluate data from biostudies to identify critical parameters (CMA, CFC, CPP) to enhance success in bioequivalence studies
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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
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Build and validate IVIVC/IVIVR for products when feasible
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Monitor and plan external development activities as required
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Search, compile and interpret scientific data, write reports, regulatory documents, manuscripts, and present work at internal and/or external meetings
Supervisory/Management Responsibilities:
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Can represent GPPS within project teams.
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Maintains relationships and can work with Contract Research Organizations (CROs).
Position Accountability/Scope:
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Reports to the Head-DMPK within GPPS.
Minimum Education:
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Masters in Pharmaceutical Science or a post-graduate degree in a related scientific discipline with a 7+ years’ relevant experience in the pharmaceutical industry.
Minimum Experience/Training Required:
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In-depth knowledge of biopharmaceutics and ADME principles and underlying mechanisms
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Thorough understanding of the impact of various factors (e.g., dosage forms, excipients, routes of administration, dosing regimens and physiological variables) on clinical outcomes
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Relevant hands-on experience in modelling and using software like DDDPlus, GastroPlus, Phoenix WinNonlin, Graph Pad Prism etc.
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Understanding of regulatory requirement of Biopharmaceutics and Bioequivalence for US, EU, and Emerging markets for generic products
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Sound knowledge on pharmaceutical development from drug discovery to marketing authorization and product life cycle
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Excellent interpersonal and verbal/written communication skills
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Highly motivated and a proactive team player
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Proven ability to effectively work in complex and multifunctional teams
