Senior Manager, Formulation R&D
Azurity Pharmaceuticals is seeking a Senior Manager for Formulation R&D to lead product development initiatives within our Research and Development team. This role involves managing external Contract Development and Manufacturing Organizations (CDMOs) and Contract Manufacturing Organizations (CMOs), as well as overseeing R&D bench scientists. The successful candidate will play a pivotal role in executing R&D projects, reviewing technical data, preparing and reviewing technical documents, and coordinating smooth technology transfers. This position is integral to our mission of delivering innovative, high-quality medications to underserved patients.
Key responsibilities include overseeing all formulation activities required for supporting product development in R&D, CROs, CMOs, and CDMOs. The role involves reviewing data generated in the R&D lab to ensure data quality throughout the product development lifecycle. The Senior Manager will supervise and monitor technical development, provide timely and accurate inputs on ongoing programs, and draft or review specifications, product development reports, and technology transfer protocols. Additionally, the role requires understanding different product development and tech transfer strategies in consultation with regulatory and intellectual property requirements, monitoring the execution of scale-up and submission batches at CMOs, and ensuring compliance with quality and regulatory requirements.
The ideal candidate will possess an M.Pharm or Ph.D. in Pharmacy with over 10 years of industrial experience in product development and scale-up. Preferred areas of expertise include extended and sustained release oral solid dosage forms, extended and sustained release suspensions (dry or liquid), and immediate release oral suspensions/solutions. Global product development experience, particularly in the U.S. market, is preferred. Experience in developing branded and differentiated products under the 505(b)(2) category and working with CROs/CDMOs is also desirable. The candidate should be adept at supporting quality management system documents such as change controls, deviations, and out-of-specifications, and facilitating the completion of required training for themselves and their team.
Azurity Pharmaceuticals offers a dynamic and inclusive work environment where innovation and dedication are valued. Employees have the opportunity to contribute to meaningful projects that positively impact patients' lives. The company supports professional growth and development, providing avenues for career advancement within the organization. Joining Azurity means becoming part of a team committed to excellence and making a difference in the pharmaceutical industry.