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

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

DIVISION:

LOCATION:

ADDITIONAL LOCATIONS:

WORK SHIFT:

TRAVEL:

MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES: