Associate Research Fellow, Biopharmaceutics and Dissolution

Pfizer Inc. - Lake Forest, IL4.2

Full-timeEstimated: $110,000 - $150,000 a year
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ROLE SUMMARY

The colleague will be the senior biopharmaceutics scientist in the new Upjohn Pharmaceutical Sciences organization. This experienced individual will conceptualize and drive the biopharmaceutics strategy and support activities for high value projects in novel and generic product categories while working closely with cross-functional product development teams. The primary focus will be solid oral dosage forms; however, the colleague will be expected to support other types of dosage forms as needed. Across dosage form types, the emphasis will be 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 both within the company and with the external scientific community. In particular, the colleague is expected to lead and/or participate in expert networks and communities of practice to access and develop best practices and leading edge capabilities.

The Upjohn Division is a highly dynamic work environment 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.

ROLE RESPONSIBILITIES

Acts as the dissolution/biopharmaceutics subject matter expert for Upjohn PharmSci. In particular, 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.
Works in close collaboration with new product development teams to address the biopharmaceutics needs of drug product design. Working in partnership with Clinical Pharmacology, develops strategies for establishing bioequivalence for drug products in development and occasionally provides support for marketed products.
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.
BASIC QUALIFICATIONS

PhD. with 10+ years of experience, or a M.S. with 12+ years, or B.S. with 15+ 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 the 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 in authoring bio-waiver justifications for solid oral drug 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 and Clinical Pharmacology.
PREFERRED QUALIFICATIONS

Experience in developing in vitro-in vivo correlations and authoring bio-waiver justifications for dosage forms beyond solid oral dosages.
OTHER

General office skills required. Periodic domestic and international travel required. Ability to perform mathematical calculations and ability to perform complex data analysis.

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%.

ORGANIZATIONAL RELATIONSHIPS

Reports to the Vice President and Head of Upjohn PharmSci within the Upjohn R&D/Medical organization.
Member of the Upjohn PharmSci Global Leadership Team.
Works in a heavily matrixed environment that requires strong working relationships with leaders and colleagues across Upjohn R&D (Product Development scientists, Clinical Pharmacology, Clinical, Medical, Preclinical Development, Regulatory, Portfolio & Project Management), Upjohn Global Supply, Commercial, Business Development and other organizations. The colleague will also interact with external vendors and consultants.
RESOURCES MANAGED

Financial Accountability

This position will not have direct functional line budget responsibility. However, the colleague will need to ensure programs utilizing external vendors/partners deliver on budget. Additionally, they may provide input into the functional line Op Plan/budget.
Individual may have some budget and spend responsibilities within projects and scientific initiatives.
Supervision

This position is an individual contributor role and will not have direct reports.
Potential to supervise a contingent worker and/or summer student intern.
Beyond internal development work, this role may manage external vendor and/or consultant resources.
Will also be expected to lead cross-function work groups, committees, etc., which requires an ability to influence and direct colleagues not having a direct line reporting relationship.

Other Job Details:
Eligible for Relocation Package: yes
Eligible for Employee Referral Bonus: yes
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.