Senior Scientist, Drug Product Formulation and Manufacturing Process Design

ROLE SUMMARY
The primary role responsibility of a Formulation Senior Scientist is to provide drug product formulation and manufacturing process design expertise to deliver the R & D portfolio, including hands-on support for end-to-end dosage form design and development activities. Responsible for early clinical through commercial formulation and manufacturing process design of pharmaceutical oral dosage forms (both immediate and modified release) for new drug candidates and product enhancement programs. May serve as Drug Product Lead on matrix Project Teams and must be a strong team player with excellent communication skills working in a complex cross-functional matrix. The role requires knowledge of pharmaceutical and engineering principles as applied to the development of solid dosage form development for both clinical and commercial scales. A strong understanding of biopharmaceutics principles and their influence on drug product formulation and pharmaceutical manufacturing processes design is highly desired.

ROLE RESPONSIBILITIES

• Leverages strong understanding of formulation, process design, and biopharmaceutics principles to design experiments and interpret in vitro, in vivo, and in silico data, then uses the resulting information to guide selection of the optimal drug delivery strategy in close collaboration with Drug Product Design colleagues globally.
• Utilizes appropriate predictive models and computational approaches to understand mechanical and physico-chemical characteristics of pharmaceutical compounds and formulations to assess performance and drive team decisions.
• Ensures the chemical and physical stability of dosage forms by collaborating with analytical chemists in the design of insightful and appropriate stability assessments.
• Generates and interprets data from 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.
• 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.
• Demonstrated abilities to work with cross-disciplinary teams and ability to partner with global, cross disciplinary subject matter experts in Pharmaceutical Sciences (Chemical Research &; Development; Analytical Research &; Development), Pharmacokinetics & Drug Metabolism, Clinical Pharmacology, Regulatory/CMC and Pfizer Global Supply (clinical and commercial drug product manufacturing).
• Strong organizational, interpersonal, written, and verbal communication skills.
• Provides laboratory support as needed to progress the projects.
• Effectively mentors other scientists.
• Maintains an awareness of and contributes to current scientific literature. Leads or supports departmental technology and continuous improvement initiatives. Actively applies new concepts as appropriate.

BASIC QUALIFICATIONS

• BS + 8 years experience, MS + 5 years experience, or PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Physical Chemistry, Chemical Engineering, Biomedical Engineering, Biophysics, or allied disciplines
• Excellent verbal and written communication skills. Strong technical writing skills.
• Successful and efficient multitasking and working on a few projects concurrently while being detail-oriented.

PREFERRED QUALIFICATIONS

• PhD in Pharmaceutics, Pharmaceutical Sciences, Physical Chemistry, Chemical Engineering + 2 years experience
• Proven ability to apply the principles of the basic sciences, such as physical and organic chemistry, thermodynamics, and materials science, to preformulation and formulation development, using a rational, scientific approach
• Experience using contemporary computational approaches to predict the properties and performance of pharmaceutical drug product performance or guide process development
• Sound knowledge of pharmaceutical and engineering principles in the solid dosage form development for both clinical and commercial scales
• Hands-on experience with formulation techniques, processing equipment, and unit operations at both the laboratory and clinical manufacturing scales.
• Experience with formulation development of modified release dosage forms
• Strong data analysis skills
• A history of success working in environments defined by innovation and initiative
• Ability to work effectively and comfortably in a multi-disciplinary team under defined timelines
• Excellent leadership, teamwork and organizational skills
• Solid verbal and written communication skills

PHYSICAL/MENTAL REQUIREMENTS

Includes activities in both laboratory and office settings; approximately 50% time in each of these settings. Some lifting in the laboratory. Ability to perform mathematical calculations and ability to perform complex data analysis.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

The position may require 10-15% travel to project meetings and support clinical, registration and validation campaigns at manufacturing sites.

Other Job Details:

• Last Date to Apply for Job: June 4, 2021
• Eligible for Relocation Package: yes
• Eligible for Employee Referral Bonus: yes

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Research and Development