Senior Scientist, Pharmaceutical Development

Infinity Pharmaceuticals
Cambridge

Infinity Pharmaceuticals is an innovative cancer drug discovery and development company that is seeking to leverage its strength in small molecule drug technologies to discover, develop, and deliver to patients first-in-class or best-in-class medicines for the treatment of cancer and related conditions.

The Pharmaceutical Development group at Infinity Pharmaceuticals is responsible for the technical support and manufacturing of drug products for clinical trials. The Formulation Scientist will work on pharmaceutical development projects at Infinity Pharmaceuticals in support of Infinity’s product portfolio. The ideal candidate will utilize experience and knowledge of current formulation techniques and be able to work in a fast paced multidisciplinary environment. The candidate will play a leading role in the development of sterile lyophilized products and sterile solution products that are in advanced clinical trials. Moreover, the candidate will be expected to support process development and validation activities to support an NDA filing. Responsibilities include: • Leading scientific role in sterile drug product development and manufacture of small molecule drug candidates • Support and coordination of process development and process validation activities to support an NDA filing • Work with Contract Manufacturing Organizations in the optimization of drug product manufacturing routes and analytical characterization • Participate in the development of drug product formulations for oral (delayed and sustained release) and intravenous routes. • Extensive knowledge of scientific literature to support formulation development of in-vivo pharmacology and clinical programs • Work collaboratively with regulatory department to maintain regulatory documentation of clinical drug candidates • Work collaboratively in team environment with Analytical, Pharmacology, Process Chemistry, Quality and Regulatory Affairs departments, and project teams as needed to support clinical programs

Experience and skills required: • Ph.D. with 3-7 years or B.S./M.S. with 10-12 years of experience in Formulation and Pharmaceutical Development • Biotech/pharmaceutical industry experience is required • Experience with pharmaceutical development is preferred • Experience with small molecule formulation and development is preferred • Scientific literature database searching experience required • Familiarity with analytical methods and instrumentation used to characterize pharmaceutical APIs and drug products • Excellent laboratory, experimental, computer, documentation and organizational skills required • Must have strong problem-solving skills and work ethic, good documentation and communication skills, as well as an attention to detail and the ability to work in a cross-functional team environment • Title will be commensurate based on experience

www.infi.com