• Plan, direct, and oversee activities related to drug substance process development • Oversee and advise on scale-up activities from lab to plant and scale-down activities from plant to lab • Evaluate, select, and actively manage external parties (CROs, CMOs) • Collaborate with Quality to ensure compliance with GMP regulations • Manage priorities and timelines while optimizing processes incorporating Quality by Design (QbD) principles • Prepare drug substance development and manufacturing timelines, and set clear outcomes for projects • Prepare and review regulatory filings (including INDs, IMPDs, NDAs) • Author/review technical reports, SOPs, and policies with the Pharmaceutical Development team • Mentor direct reports and team members including providing feedback and coaching