Formulations Development Consultant for Oncology Programs

LogisticsDirector Level20 hours per week for 3 monthsRemote, ideally from Ideally East Coast BasedTravel Requirements: N/AHourly rate: $130 - $240 p/hrAboutWe are an innovative biotech company committed to transforming the treatment of cancer, neurological, and other important diseases with novel therapies that eliminate disease-causing proteins. We are looking for an experienced Formulation Development consultant to join our Pharmaceutical Development team. This person should be an experienced formulator with experience in oral solid dosage forms and oral solid dosage characterization. They should also have experience overseeing the formulation activities of CMOs. The ideal consultant should have familiarity with the complete development cycle, including an understanding of regulatory and manufacturing, and have had experience from the discovery to the manufacturing phase.ResponsibilitiesAssess project progress and provide constructive feedback, while supporting the evaluation and development of technical performance, problem solving approaches, and capabilities across team members.Planning, designing, and supervising the execution of experiments via external vendors and collaborators, and interpreting results to properly characterize novel drug candidates.Applying formulation and manufacturing principles, theories and techniques to develop the best possible phase-appropriate formulations and manufacturing processes. Troubleshooting formulation short-comings by using a combination of modeling and real-time data.Develop, execute, and evaluate formulation development studies, including API evaluations, stability, compatibility testing, etc.Optimize drug formulations for oral solid dosage for IND-enabling and Registration phase studies.Working effectively with CROs/CMOs by providing technical oversight to develop formulations and to ensure that the clinical manufacturing needs are met.Ensure proper and adequate supplies for all clinical trials, including planning, packaging, labeling, distribution, storage, and destruction of investigational product at clinical sites.Ideal CandidateAt least 7+ years of experience in drug product, pre-formulations and formulation development for early to late phase programsExperience with small-molecule formulations is requiredExpertise in oral solid dosage form is requiredExperience with drug product stability assessment design, execution, and reportingExperience with analytical method developmentExperience with clinical trial material preparation including packaging, labeling, distribution, storage, and destruction of investigational product at clinical sites.Experience engaging and coordinating with CDMOs and external vendorsExperience with packaging design and stability studies, including assignment of shelf-life a plus.