The Executive Director, Preformulation leads a diverse team of scientists and engineers who employ advanced characterization approaches to understand and predict molecule physical and chemical stability in the context of the formulation composition and process. The data collected from preformulation experiments, in total, form the basis of rational drug product development and provide the mechanistic understanding that fully supports the tactics and long range control strategies.
The desire to apply new/novel characterization approaches to complex scientific problems is essential.
Experience in crystallization, salt and polymorph screening would also be valuable.
A strong knowledge of novel drug delivery systems including specialty drug/device combination products is desired.
Experience in the characterization of drug substances and formulations spanning multiple drug modalities would also be valuable.
Experience in utilizing design of experiments (DOE) methodology and statistics/data visualization approaches would be desirable.
A good understand of the correlation between product attributes and biopharmaceutics/pharmacokinetics is also desired.
The preformulation leader champions the role of preformulation data in developing product, representing the data in various forums, and ensuring visibility of key data to influence product design.
Understanding GXP laboratory operation and documentation would be helpful as well as a desire to leverage predictive approaches to extrapolate long term drug product stability.
Key leadership success criteria include building strong relationships with peers and cross-function partners within drug substance, discovery and manufacturing.
The individual would be expected to drive to the highest standards of scientific and operational effectiveness with the team.
Responsible for creating a learning environment, open to suggestions and experimentation for improvement as well as an environment where employees feel appreciated and are supported, enabling them to excel.
The leader will have the ability to drive practical research innovations that lead to strongly performing products, IP and external publication/presentation presence.
The leader links with the external scientific and regulatory community to understand and influence trends as well as to bring new technology and approaches back to Merck.
The leader also creates and maintains a compliant and safe work environment.
Qualifications
Education:
PhD in chemistry, pharmaceutical science, chemical engineering or relevant scientific discipline.
Required:
Minimum of 7-10 years of experience in the pharmaceutical R&D, with relevant experience in Pharmaceutical Science.
Preferred:
Direct experience in advanced analytical characterization approaches, solid state chemistry, physiochemical characterization, discovery pharmaceutical science and/or biophysical characterization.
3 years scientific supervision or people management experience
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