Postdoctoral Research Fellow- Pharmaceutical Sciences

Job Description

Be a part of the legacy: Postdoctoral Research Fellow Program

Our Research Laboratories' Postdoctoral Research Fellow Program aims to be a best-in-industry program for industrial postdoctoral researchers, designed to provide you with an academic focus in a commercial environment. With the resources, reach, and expertise of a large pharmaceutical company, postdoctoral researchers will be positioned to excel in an institution committed to breakthrough innovation in research and discovery.

Job Description

Our company's Research Laboratories in Boston are focused on driving discovery research. Our discovery research site offers state-of-the-art resources to explore the most promising science combined with our company's world-class R&D expertise in small molecules, peptides, biologics, and nucleic acids.

The postdoctoral fellowship is a multi-disciplinary project involving Discovery Pharmaceutical Sciences (DPS), Pharmacokinetics, Dynamics, Metabolism and Bioanalytics (PDMB), and Pharmaceutical Sciences Biologics Dev. & Biopharmaceutics (BDB).

• DPS is a research group that enables drug discovery and drug product development by applying pharmaceutical science and drug delivery research from target identification through clinical candidate selection for both small and large molecules. DPS influences the molecular design of novel therapeutics and the selection of viable formulation strategy through physicochemical property profiling (solubility, stability, thermal properties, etc.), early absorption prediction, de-risking strategies, and communication across functions and downstream to development partners.
• PDMB supports the development of small and large molecule drug discovery and development by characterizing ADME properties. This involves the use of in vitro and in vivo ADME assays such as metabolic stability, permeability, enzyme kinetics, protein binding, in silico tools, and other bioanalytical tools and techniques for supporting dose, bioavailability, and drug-drug interaction predictions. Modeling and simulation tools such as in vitro mechanistic modeling and Physiologically Based Pharmacokinetics (PBPK) modeling are extensively used during the drug discovery process.
• BDB supports the development of drug candidates spanning preclinical toxicology studies through commercialization. Biopharmaceutics scientists proactively develop and execute a comprehensive biopharmaceutics strategy that leverages innovative in vitro, in vivo, and in silico PBPK and PK modeling tools, while advancing the underlying biopharmaceutics science within the organization and the external scientific community.

We are looking for a strong candidate for the Post-doctoral Fellow position to identify mitigation strategies for compounds for which low permeability/absorption limits systemic exposure. The fellow will develop in vitro and in silico ADME models for compounds where complex ADME mechanisms may occur, e.g., for BCS III and IV drugs. Furthermore, mechanisms for food effect that occur with low permeability drugs are not well understood and will also be investigated. This post-doc fellow will leverage expertise from DPS, PDMB, and BDB and lead a multi-disciplinary project. The project involves 3 major aims:

• Understand, assess, and mitigate permeability through drug design and/or formulation development.
• Identify suitable permeability input in models used for bioavailability/dose prediction.
• Address predictivity challenges with complex food effect for low permeability compounds

Primary Responsibilities will include:

• Implementing in vitro assays that enable a biopredictive assessment of permeability, analyzing molecular properties impacting permeability, and establishing robust mitigation strategies for poor permeability.
• Developing and implementing PBPK models - Continuous absorption model, Qgut, GastroPlusTM, SimcypTM - for improved bioavailability prediction. The postdoctoral fellow will collate internal and external bioavailability data for BCS II, III, and IV compounds and evaluate these compounds in predictive models. Critical input parameters will be identified and / or experimentally collected to support the model-informed formulation or drug development. The fellow will build foundation for an interface that will eventually encompass bioavailability considerations.
• Analyzing and mitigating food effects for a set of BCS III/IV Drugs. Permeability, metabolism and transporter data will be integrated in mechanistic PBPK models using in silico and in vitro data to identify negative food effect a priori. The postdoctoral fellow will develop strategies for improved understanding and mitigation of complex food effects.

Desired Qualifications:

Minimum education required:

• A Ph.D. in biopharmaceutics with experience in formulation development and modeling experience or strong knowledge of Pharmacokinetics/ ADME or Systems Pharmacology and modeling experience

Required Experience and Skills:

• Coursework in pharmacokinetics and understanding of principles of physiologically based pharmacokinetic modeling.
• Experience in developing and performing in vitro assays (e.g., permeability, enzyme-kinetic assays)
• Familiarity with formulation development of small molecules
• Demonstrated strong verbal as well as written communication skills and ability to work effectively with team members of diverse skill sets and backgrounds.
• Demonstrated self-motivation to take ownership and accountability of issues and drive them to completion.

Preferred Experience and Skills:

• Experience with physiologically based pharmacokinetics modeling software (e.g., Simcyp, GastroPlus, PK-Sim)
• Proficiency in either PK, PK/PD, PBPK/ PD, or popPK modeling (e.g., MATLAB, Python, Phoenix) is a plus.

Postdocfellow

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Employee Status:
Regular

Relocation:
Domestic

VISA Sponsorship:
Yes

Travel Requirements:
10%

Flexible Work Arrangements:
On-Site

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
na

Requisition ID:R250815