Senior Executive – Biopharmaceutics
Job Description
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:
- 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
Supervisory/Management Responsibilities:
- Can represent GPPS within project teams.
- Maintains relationships and can work with Contract Research Organizations (CROs).
Position Accountability/Scope:
- Reports to the Head-DMPK within GPPS.
Minimum Education:
- 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:
- In-depth knowledge of biopharmaceutics and ADME principles and underlying mechanisms
- Thorough understanding of the impact of various factors (e.g., dosage forms, excipients, routes of administration, dosing regimens and physiological variables) on clinical outcomes
- Relevant hands-on experience in modelling and using software like DDDPlus, GastroPlus, Phoenix WinNonlin, Graph Pad Prism etc.
- Understanding of regulatory requirement of Biopharmaceutics and Bioequivalence for US, EU, and Emerging markets for generic products
- Sound knowledge on pharmaceutical development from drug discovery to marketing authorization and product life cycle
- Excellent interpersonal and verbal/written communication skills
- Highly motivated and a proactive team player
- Proven ability to effectively work in complex and multifunctional teams