● Manage R&D activities and staff within the R&D department.
● Technology transfer of new products for OSD and injectable products.
● Develop and validate methods to test pharmaceutical raw materials and finished products for strength, identity, impurities, and dissolution performance by commonly used techniques.
● Prepare SOPs, guidance, protocols, and reports, to support laboratory GMP function in compliance with FDA, ICH, and other regulatory guidance.
● Work with other sections and departments within the company as needed to facilitate the successful development and launch of new products.
Requirements
● Accredited PharmD/Ph.D. degree in Pharmaceutical Sciences or Master’s degree/Ph.D. in Chemistry with 6 years of experience, laboratory experience, and scale-up in pharmaceutical R&D environment with experience in both OSD and injectable dosage forms, preferred Hazard.
● Extensive knowledge of cGMP, USP, WHO, FDA, and ICH guidelines.
● Highly skilled in conducting and understanding both injectable and OSD formulation and analytical method development and validation.
● Outstanding communication skills (verbal and written).
● Ability to manage multiple projects in a fast-paced environment.
● Ability to identify and resolve project issues, including those related to timing, resources, and funding, to prevent delays in project milestones.
● Ability to effectively allocate resources, and to be accurate and current with data and information.