Job Description

ROLE SUMMARY

We are seeking a Principal Scientist with expertise in the development and application of PBPK (physiologically-based pharmacokinetic) models and PBBM (physiologically-based biopharmaceutics modeling) to facilitate in vitro and in vivo assessments of biopharmaceutics attributes and risks for new drug products. The Principal Scientist is a member of the Global Biopharmaceutics Group, which is part of the Drug Product Design department, and which is engaged in biopharmaceutics-based design of oral, topical, and parenteral drug delivery systems. As a member of our global team, the Principal Scientist will support the development and biopharmaceutic understanding of a diverse range of drug candidates and drug product delivery systems as part of multi-disciplinary project teams. The Principal Scientist will also have the opportunity to grow the technical capabilities of the Global Biopharmaceutics Group by identifying and pursuing new opportunities with in silico and in vitro approaches to predict drug product performance. The candidate will report to a Global Biopharmaceutics Team Leader in Groton, CT, USA.

ROLE RESPONSIBILITIES

Work in multidisciplinary teams composed of scientists with experience and expertise in biopharmaceutics, oral absorption modeling, pharmaceutical sciences, biology, clinical pharmacology, synthetic organic chemistry, chemical engineering, material science, etc.
Partner closely with clinical pharmacology and PDM (Pharmacokinetics, Distribution, and Metabolism) project team reps to ensure alignment on biopharmaceutical aspects for drug product development programs
Utilize principles of physical, biophysical, physical-organic chemistry, and chemical engineering to understand, troubleshoot, and solve practical problems associated with in vitro and in vivo performance of drug products and drug delivery systems
Develop or implement computational predictive tools for mass transport such as dissolution of particles, release of drug from drug delivery platforms, assess self-assembling systems in solution, oral absorption modeling of drug molecules in multi-component systems, and in vitro performance attributes of complex drug products and drug delivery systems and manufacturing processes
Provide input and insights to conduct experimental investigations to enable development of leading edge in vitro and in silico capabilities for the design of complex drug delivery systems intended to provide desired pharmacological outcomes for patients
Develop strategic collaborations with academic and industrial researchers for addressing gaps in fundamental or applied science related to biopharmaceutics with a focus on mass transport phenomenon using principles of physics, physical chemistry, and chemical engineering associated with solution and solid-state thermodynamics of drugs
Author biopharmaceutics sections of regulatory submissions, by providing succinct descriptions of well characterized and modeled drug delivery systems and their biopharmaceutical performance.
Publish research in reputed scientific journals and give presentations at national and international conferences.
BASIC QUALIFICATIONS

PhD with 5 years post-doctoral experience, or MS with 10+ years, or BS with 15+ years of experience in industry in Chemical Engineering, Physical Chemistry, Biophysical Chemistry, Biophysics, Physics, Physical Organic Chemistry, Pharmaceutics, Pharmaceutical Science
Experience in the use of appropriate biopharmaceutics modeling and computer software (e.g. Simcyp, GastroPlus, Phoenix WinNonLin, etc.) to support drug product development across both pre-clinical and clinical stages.
Demonstrated ability to develop relevant computational models for predictive design and performance of novel drug delivery systems with focused biopharmaceutics applications.
Experience with evaluating the risk profile and risk mitigation strategies for drug product development from a biopharmaceutics perspective
Experience with pharmacokinetic study data analysis, including deconvolution and in vitro / in vivo relationship
Working knowledge of drug product formulation, including immediate release, modified release, topical and parenteral delivery systems
PREFERRED QUALIFICATIONS

Experience in interpretation of experimental thermodynamic and kinetic data associated with biopharmaceutics and drug delivery systems; solve problems by combining data with mathematical modeling of underlying phenomenon
Experience in the use of appropriate computer programming languages (e.g. Matlab, C++, Python) for novel problem solving to complement commercially-available PBPK software capabilities
Strong interpersonal written, and verbal communication skills
Ability to prioritize and manage multiple projects and activities while meeting tight deadlines
Proactive in problem-solving and be able to independently manage timelines and priorities
Ability to work independently to drive project forward, as well as collaboratively in a multidisciplinary team environment
Ability to work remotely with supervisor and globally located biopharmaceutics and multi-disciplinary team members
Established industry and academic network in the biopharmaceutics space
PHYSICAL/MENTAL REQUIREMENTS

Ability to perform mathematical calculations and ability to perform complex data analysis

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Work travel: 5-10%

Additional Information:

Relocation support available
Work Location Assignment: Flexible
Employee Referral Eligible

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.