Pfizer Senior Principal Scientist, Dissolution/Biopharmaceutics in Lake Forest, Illinois
Department Marketing Statement
Join Pfizer, one of the world's leading pharmaceutical companies. We are seeking an accomplished Dissolution/Biopharmaceutics lead scientist to join our Pfizer Essential Health R&D organization in Lake Forest, IL. This individual will be placed in our new Non-sterile Product Development group, part of our growing Pharmaceutical Sciences organization. The work is highly dynamic, and happens in an atmosphere with a "start-up" feel. As an early hire, the individual will have significant opportunity to influence future vision and establish the reputation of the group.
The colleague will be a senior biopharmaceutics scientist in Pfizer Essential Health (PEH) Pharmaceutical Sciences organization. This experienced individual will conceptualize and drive the biopharmaceutics aspects of high value projects in novel and generic product categories while working closely with product development teams. A wide range of dosage forms will be covered in the sterile and non-sterile products spaces, with emphasis on linking dissolution to bio-performance. Work will primarily focus on new product development, but will occasionally extend to marketed product support. The colleague may also be called on to provide technical input into business development evaluations and participate in due diligence activities.
As a senior technical leader, this individual will have opportunity to develop alliances across the larger Pfizer organization and external scientific community. The colleague will also maintain a close connection to Pfizer Innovative Health's world-class Biopharmaceutics group in Groton, CT, and have access to their leading edge capabilities.
Acts as the dissolution/biopharmaceutics subject matter expert for both PEH PharmSci Non-sterile and Sterile Product Development functions.
Works in close collaboration with new product development teams to address the biopharmaceutics needs of oral, parenteral and transdermal drug product design.
Develops strategies for establishing bioequivalence for drug products in development and occasionally provides support for marketed products.
Participates in project meetings and provides SME level support.
Develops and advances concepts of translational biopharmaceutics with a focus to improve predictive capabilities by linking in vitro drug product performance attributes (mainly dissolution) to in vivo performance attributes.
Authors/Co-authors bio-waivers where appropriate.
Provides input into CTD Modules 2.7 and 3.2.P.2.
Oversees the development of bio-relevant testing methods and the justification of clinically relevant product specifications.
Keeps current on modern trends in drug dissolution research and their regulatory implications.
Trains/coaches other scientists on dissolution methodologies.
Ph.D. with 7+ years of experience, or a M.S. with 10+ years, or B.S. with minimum 14+ years in the pharmaceutical industry. Degree should be in Pharmaceutics, Pharmaceutical Science, Chemistry, Biochemistry, Chemical Engineering, Biophysics or a related field.
A demonstrated capability to build mechanistic models for predicting exposure following oral and other routes of delivery.
Experience in biopharmaceutics modeling, physicochemical (solubility & dissolution) and biological (passive, transporter mediated, efflux) transport phenomena, interpretation and use of in vitro permeability measurements, in vivo/in vitro drug metabolism studies, and interpretation of pre-clinical and clinical pharmacokinetic data.
Sound understanding of drug product development process, from pre-formulation and prototype development through process scale-up.
An understanding of Quality-by-Design principles and setting clinically relevant product specifications.
Experience is authoring bio-waiver justifications for sterile and non-sterile products.
Track record of successfully applying high-level scientific judgment in a variety of complex and unprecedented situations.
Strong consultative and partnering skills.
Comfortable and thrives in a dynamic, fast-paced environment with a start-up atmosphere.
Demonstrated abilities to work in multi-function teams and ability to partner with cross disciplinary subject matter experts in Pharmaceutical Sciences.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Work schedule may be non-routine due to periodic communications between US, Europe and Asia time zones. Travel to support business needs will be required at a level of approximately 10%.
EEO & Employment Eligibility
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.
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Eligible for relocation package
Eligible for employee referral bonus
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.