Postdoc - Postdoctoral Fellow - A Translational Strategy for Describing Supersaturation Potential
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
AbbVie is a global, research-based biopharmaceutical company with a mission to use expertise of dedicated scientists and unique approach to innovation and to develop advanced therapies that address some of the world's most complex and serious diseases. The Postdoctoral Program is designed for true investigational and experimental research. The enriching training program offers a balance of structured learning and work experience which fosters a learning environment to advance individual development with accessibility to high-level knowledge building across the drug development continuum.
To be successful, we need outstanding individuals willing to challenge themselves to find the best solutions for our patients. The AbbVie Postdoctoral Program is one way we are doing just that.
Through our Postdoctoral Program, we are hiring postdocs from key academic institutions for preferred areas of science in the U.S., while providing a unique opportunity for participants to build a solid career foundation in the pharmaceutical industry while building the AbbVie brand as an employer of choice for scientific talent. Participants in the Postdoctoral Program play an integral part in our continued success and will help us to further grow as a leader in our industry. The successful candidate will conduct novel and impactful research over a 2-3-year period. High-impact publications and presentations at scientific meetings are expected outcomes along with the opportunity to gain valuable experience working within a top-tier biopharmaceutical company. This assignment is expected to be for two years minimally and no more than three years.
The Solid state Chemistry group in Development Sciences organization at Abbvie works within cross-functional teams to support all solid-state related activities through all phases of development i.e. Lead Optimization to Process Validation. At the Discovery-Development interface, solid state chemistry team members work closely with colleagues from Pharmaceutics, Discovery, DMPK-BA, PCS & Process Chemistry to identify fit to purpose solid form of the API, obtain relevant Physchem data to guide lead optimization, help selection of best molecule for development, and develop scalable API isolation processes for early clinical studies. During Phase II, they work with engineers and formulation scientists to establish structure-property-performance correlations and deliver commercial API isolation processes with optimized physical properties. In the final stages of development, Solid State Chemists help align control strategies across API and drug product and transition isolation processes and relevant physical characterization methods to commercial manufacturing sites. Throughout development, they work with relevant teams to ensure successful regulatory submissions. The postdoc will be a part of solid-state chemistry group and working in highly cross functional environment and collaborating closely with Pharmaceutics, Formulations, and DMPK-BA group.
Project Overview and Aims
Enabling solid forms and formulations with supersaturating potential are frequently used to address poor aqueous solubility of pharmaceutical molecules. Various in vitro tools are used to evaluate in-vivo relevant phase transformations of supersaturating formulations to qualitatively rank order the absorption potential of clinical formulation options. However, a key uncertainty that remains is translation of observed invitro profiles to in vivo results for prospective modeling of product performance in humans. In addition, there are opportunities to enhance the correlation between in vitro and in -vivo results by optimizing/developing innovative ways to map potential phase behavior as well as modeling complex thermodynamic, and kinetic physicochemical behavior in the context of drug absorption. The overarching goal of this project is to develop in vitro tools to support the development of in vitro to in vivo correlations for supersaturating solid forms and formulations. A key goal of the project will be to leverage in silico absorption models to improve mechanistic understanding leading to successful correlations and guide solid form and formulation development. The research will utilize both in-house as well as model compounds
Specific aims will include:
- Prepare solid forms and formulations of model compounds with supersaturating potential and characterize their phase behavior (dissolution and precipitation) utilizing available/novel in vitro methods
- Correlate in vitro test results to in vivo performance in preclinical species
- Optimize and develop novel in vitro test methods to better describe phase behavior and drug transport in the small and large intestine as well as the diffusion across the mucosa to enhance robustness of correlation to in vivo
- Utilize in silico absorption models to enhance the correlation and understanding of in vitro and in vivo results
- Incorporate in vitro characterization data of phase behavior from supersaturating solids and formulations into absorption models to further correlation to in vivo
- Translate observed/modeled dissolution and precipitation behavior towards prediction of human performance
- Utilize available clinical data from the literature/internal compounds as a training set to refine and validate in silico models
- Propose a best-practice approach for the characterization (including application of novel in vitro test methods and in silico models) of supersaturating solid forms and/or formulations to enable prioritization in the absence of traditional PK studies in preclinical species (potential for publication on novel in vitro test methods and the overall workflow/strategy).
Note: The outcomes of this research project will lead to integrated and efficient product development by earlier assessment of solid forms within the context of the formulation. The translational framework will reduce the required preclinical studies in support of product design, enhance confidence in translatability of results from in vitro test methods and result in more robust inputs into early PBPK models
- Successful completion and defense of a PhD in pharmaceutics, medicinal chemistry, chemistry, or chemical engineering with a demonstrated interest in drug development research. Minimum graduate school GPA 3.0; 3.5 preferred. Graduate of accredited and nationally ranked university.
- Record of publication of at least two high-quality papers in a prestigious top-tier review journal(s) preferably with solid form design, physicochemical characterization, characterization of drug release with in vitro test methods, and absorption modeling.
- Excellent problem-solving skills including critical and analytical thinking.
- Excellent communication, leadership, and project management skills.
- Demonstrated scientific writing skills and strong verbal communication skills.
- Demonstrated ability to independently design and execute experiments, interpret data, and identify appropriate follow-up strategies.
- Proven track record of teamwork, adaptability, innovation, initiative, and integrity. Global mindset to thrive in a diverse culture and environment.
- Ability to multitask and work within timelines.
- Work authorization in the United States
- Basic familiarity with the pharmaceutical solid state, physicochemical characterization, formulation design, drug dissolution, and oral drug absorption/pharmacokinetics
- Provide three letters of recommendation from thesis advisor and thesis committee members
- Provide letter of intent to pursue a Postdoc
Key Leadership Competencies:
- Builds strong relationships with peers and cross functionally with partners outside of the immediate team to enable higher performance
- Learns fast, grasps the "essence" and can change course quickly where indicated
- Raises the bar and is never satisfied with the status quo
- Creates a learning environment, open to suggestions and experimentation to drive the science in the field of interest
- Embraces the ideas of others, nurtures innovation and manages innovation to reality
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.