Senior Manager, Pharmaceutical Sciences

Job description

Overview The Senior Manager, Pharmaceutical Sciences applies broad pharmaceutical sciences and CMC expertise to develop and maintain commercial products that are safe, effective, compliant, and robust across the product lifecycle. This role will provide technical leadership for an oral suspension product and a sterile injectable product, including formulation/process development, technology transfer, external manufacturing (CDMO/CMO) oversight, investigations, and post-approval lifecycle management. Responsibilities: - Interact with external manufacturing partners and testing laboratories in support of management of development and tech transfer projects – clinical supplies, commercial and post-marketed products. - Participate in the development and review of validation strategies for new products and processes, including assessment of vendor change controls, risk assessments, annual product reports, and process validation protocols and reports. - Provide technical support for Supply Chain, Quality Assurance (QA) and Regulatory Affairs Departments, and Provide scientific direction and expertise to cross-functional teams. - Be responsible for Risk Management activities including ris...