Scientist II, Drug Product

Role: Scientist II supporting drug product development within Pharmaceutical Development & Manufacturing for small molecule oncology therapies targeting RAS mutations. Objectives include designing and executing formulation and process development activities from early to late-stage clinical phases, ensuring scalable, robust, and compliant manufacturing processes. Responsibilities encompass preformulation, formulation, process scale-up, technology transfer, validation, and overseeing outsourced manufacturing at CDMOs; supporting regulatory documentation like INDs and NDAs; and collaborating cross-functionally with teams such as Analytical Development, Quality, Regulatory, and Clinical Supply. The role involves travel up to 20% to oversee external partners. Requirements include a Ph.D. with 3+ years or a relevant bachelor’s/master’s degree with industry experience in small molecule drug product development, solid oral dosage formulation expertise, and familiarity with global regulatory standards (FDA, EMA, ICH). Preferred qualifications include advanced degrees and regulatory submission experience. High-value specifics involve late-stage clinical oncology programs, GxP compliance, and cross-functional collaboration in a fast-paced, innovation-driven environment.