Company
Pharmaceutical
SeniorExecutive–Biopharmaceutics
Neural analysis suggests this role is
optimal for Senior candidates.
“Senior Executive – Biopharmaceutics. Skills: Biopharmaceutics, Pharmacokinetics, Modelling, Simulation. Support product innovation and development. Provide inputs to formulation teams”
Industry & Context.
Root cause analysis
Continuous sitting
What They're Looking For.
Must Have
7+ years relevant experience, In-depth knowledge of biopharmaceutics, In-depth knowledge of ADME principles, Thorough understanding of impact factors, Relevant hands-on modelling experience, Relevant hands-on simulation experience, Understanding of regulatory requirements, Sound knowledge on pharmaceutical development, Excellent interpersonal skills, Excellent verbal communication skills, Excellent written communication skills
Nice to Have
Masters in Pharmaceutical Science, Post-graduate degree in related scientific discipline
What You'll Do.
Support product innovation and development
Provide inputs to formulation teams
Provide inputs to analytical teams
Identify bio-relevant media
Identify characterization tools
Identify methodologies
Select formulation strategies
Evaluate biostudy data
Identify critical parameters
Enhance success in bioequivalence studies
Perform mechanistic modelling
Simulate in vitro dissolution
Predict in vivo pharmacokinetic profile
Monitor external development
Plan external development
Search scientific data
Compile scientific data
Interpret scientific data
Write regulatory documents
How You'll Work.
Team & Collaboration
Global/regional cross-functional teams; Multi-disciplinary project teams; Contract Research Organizations (CROs)
Communication Scope
Verbal communication; Written communication
Full Job Description
## **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 wi
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