Reporting to the Chief Scientific Officer, the candidate will be responsible for analytical method development, and testing for sterile dosage forms, especially injectables based out of the North Brunswick, NJ research lab. This position will be a key member of the product development team and hence will be expected to contribute cross-functionally from product ideation to filing. As an entrepreneurial, and growing company, the work environment will be fun, flexible and fast-paced.
Developing analytical methods, and perform testing of pharmaceutical raw materials, in-process samples, finished products, and stability samples using instrumentation such as HPLC, UPLC, GC, UV/VIS, FTIR, dissolution apparatus, particle size analyzer, etc.
Setting specifications for the drug product
Authoring method validation protocols, performing method validation and writing validation reports
Perform routine maintenance, and calibration of lab equipment
Participating in method transfer activities when necessary; Overseeing sample testing and method development at third party sites
Authoring SoPs as needed to support lab operations
The ideal candidate will be an expert in method development (specializing in HPLC) to support small molecule injectable pharmaceutical products, knowledgeable in ANDA filing requirement, hard-working, flexible, able to multi-task and ambitious. A degree in chemistry and at least 5 years of experience in the regulated pharmaceutical industry. Experience encompassing the entire life cycle including method development, application filing, deficiency management, and approval highly desirable.
Compensation will be commensurate with the candidate’s experience and education.
If you feel your background and experience are a close fit, please apply via LinkedIn: https://www.linkedin.com/jobs/view/1841885840/