Job Scope & Purpose:
Our Greater Boston area client with a clinical pipeline in inhaled therapeutics is seeking an exceptional and motivated Process Development Engineer to lead a team overseeing drug product process development and scale-up for multiple programs through clinical development. The ideal candidate will have ample industry experience leading programs through various stages of clinical development, and can lead programs to registration and commercialization.
Primary Job Requirements:
BS/MS/PhD in Chemical Engineering or Material Sciences with minimum of 10 years industry experience
Experience in developing multi-step drug product manufacturing processes, including preferred expertise in particulate-based technologies
Previous experience from phase 1 through phase 3, with commercialization experience preferred but not required
Small molecule drug product development experience within any dosage form (solid oral, liquid, inhaled, lyophilized, injectable, etc.), with preference given to experience with solid-based dosage forms
Previous experience managing and mentoring junior engineers and scientists required
Excellent communication and written skills required due to the collaborative nature of the position
Good knowledge of interplay between formulation and process, solid state chemistry, stability, and material science
Working familiarity with regulatory guidances pertaining to pharmaceutical development and risk management (ICH Q8, Q9)
Ability to travel between 10-20%, both domestically and internationally
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