Senior Principal Scientist

ROLE SUMMARY

Pfizer’s Drug Product Design group is seeking team members with a desire to bring new, cutting edge medicines to patients around the world.  Our team members use science and technology to design, characterize and develop drug product formulations from candidate selection to commercial launch.  

You will be able to leverage your existing scientific knowledge, as well as develop in new areas, to evaluate the chemical & physical stability, bio-performance and manufacturability of the drug product across a diverse range of therapeutic areas.

You will be responsible for formulation and manufacturing process design of pharmaceutical oral dosage forms (for new drug candidates and product enhancement programs.  You will participate in multi-disciplinary teams during the formulation development, process scale up, and technology transfer of conventional and continuous processing technologies including immediate release, modified release, pediatric and other specialized technologies to our clinical and commercial manufacturing sites in the Pfizer Global Supply organization.

You may serve as the Drug Product Leader on matrix project teams and must be a strong team player with excellent communication skills working in a complex cross-functional matrix.

This position also offers the opportunity for cross-training and growth in multiple technical areas to encourage a flexible working environment.  Enjoy the entrepreneurial mindset and infrastructure to develop new technologies and processes for drug delivery and dosage form manufacture while having access to the resources of a larger company. 

The role requires knowledge of pharmaceutical, materials science, physical chemistry and engineering principles as applied to the design of solid dosage forms, biopharmaceutics, pharmacokinetics and advancement of drug delivery platforms for immediate and modified release including pediatric design.

As member of the Drug Product Design group you will interact closely with other Pharm Sci partner lines (e.g. Analytical R&D, Chemical R&D, Global CMC, Pharm Sci Operations, Drug Product Supply, Quality Assurance) and other lines involved in developing drug assets such as Clinical Pharmacology, Clinical Sciences, Pharmacology & Drug Metabolism and Pfizer Global Supply.

Finally, this position will challenge you to pursue scientific excellence and creativity, in collaboration with industry-leading experts across multiple scientific disciplines. 

Role Responsibilities  

• Leverages expert technical knowledge in chemistry, pharmaceutics, engineering and/or materials science fundamentals to the design and development of immediate and modified release formulations and manufacturing process understanding.

• Designs and executes laboratory and computational experiments to support novel solid oral drug delivery platforms, initiatives, and portfolio-driven projects.

• Addresses complex multi-disciplinary scientific challenges at a portfolio level, inclusive of novel formulation platforms.

• Guides scientific direction and project decisions through biopharmaceutics modeling tools, physicochemical (solubility, precipitation, & dissolution) and biological (passive, transporter mediated, efflux) transport phenomena, and pre-clinical and clinical pharmacokinetic studies to influence drug product development.

• Advances predictive models and computational approaches to understand mechanical and physico-chemical characteristics of pharmaceutical compounds and formulations to assess drug product performance and drive team decisions.

• Leads or supports departmental technology and continuous improvement initiatives.

• Seeks collaboration and develops novel methodologies with cross-disciplinary teams to solve problems and align on development strategies

• Authors and provides guidance to authors of regulatory documents supporting drug product development, including relevant drug product sections of IND submissions and CTD applications and associated queries to regulatory agencies.

• Strong organizational, interpersonal, written, and verbal communication skills.

• Effectively mentors other scientists in the varied disciplines of drug product design.

• Strives to grow scientifically, contributes to current scientific literature and influences both the external and internal environment

Minimum Qualifications  

• BS with 10+ years of experience, or PhD with 7+ years of experience in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or allied discipline.

Preferred Qualifications 

• Extensive practical experience working within de