• Lead development of small molecule solid-oral dosage formulations from pre-IND to Phase 3 including: • Assess API physical and chemical properties as it relates to drug product manufacturability, performance and stability • Evaluate phase-appropriate formulation approaches and enabling technologies to achieve the target drug product profile • Design experiments to optimize the formulation and manufacturing process • Oversee formulation development and GMP manufacturing activities at CDMOs: • Lead DP endor section activities as necessary ad manage vendor relationship • Effectively communicate scope of work, timelines, and priorities and monitor the deliverables and performance as it relates to the project objectives • Drive review of batch records, protocols, reports, and other vendor documents • Provide technical expertise and guidance to troubleshoot development and manufacturing challenges • On-site presence for batch manufacturing activities at the CDMO as needed • Represent formulation development group in cross-functional team and effectively communicate project status and technical risks with appropriate solutions • Work closely with QA to ensure GMP activities are conducted in accordance with internal QMS • Author/review internal technical reports and drug product sections of regulatory filings • You can participate and work effectively with multiple cross-functional teams. • You have strong interpersonal skills and understand relationships are key to being successful. • You are a leader. Teams love working with you, and you are someone who takes pride in mentoring and supporting the careers of others. • You’re a team player who is willing to roll-up your sleeves and get the job done.