Principal Scientist, Pharmaceutical Science & Technology

Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related field with a minimum of 8+ years of relevant industry experience; or M.S. with 12+ years of experience., Extensive and hand-on experience in small molecule drug product development is essential, with experience in parenteral, solid oral and semi solid dosage forms (including modified release technologies)., Broad, end-to-end CMC experience supporting assets from Phase I through Phase III and regulatory submission (NDA). Direct experience authoring CMC sections for INDs and NDAs., Experience in supporting due diligence, licensing, and acquisition activities from a technical perspective., Knowledge of analytical chemistry and its application to the characterization and analysis of DS and DP (e.g., HPLC/UPLC, dissolution, GC, spectroscopy, solid-state characterization)., Demonstrated experience in process scale-up and technology transfer to GMP manufacturing facilities., Comprehensive understanding of global CMC regulatory requirements (FDA, EMA, ICH)., Excellent project management, communication, and leadership skills with the ability to influence cross-functional teams and external partners., Practical experience conducting statistical analysis of pharmaceutical data is essential, preferably using JMP stability application., Fluent knowledge of English, Experience with biologic product development (DS/DP) and a successful BLA submission., Experience with other complex dosage forms (e.g., transdermal, inhalation & topical)., Knowledge of combination product development (e.g., auto-injectors, delivery systems)., Familiarity with Quality by Design (QbD) principles and Design of Experiments (DoE)., Experience with Nitrosamines, associated Regulatory landscape, the application of CPCA framework and mitigation strategies.

private medical care, life insurance, retirement pension plan, extra social benefits, sharing the costs of tickets to the movies, theater, holiday funds