[Hiring] Program Manager II – Pharmaceutical Development & Clinical Supply @MRIGlobal

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The Program Manager II leads cross-functional programs in early-phase pharmaceutical development and clinical supply chain operations, ensuring technical excellence and phase-appropriate cGMP compliance. This is an ideal role for a seasoned professional who enjoys the rigor of science but prefers the broader scope of program management. This role oversees Chemistry, Manufacturing, and Controls (CMC) activities for investigational drug products, including drug substance and product development, analytical testing, stability studies, and packaging/distribution for Phase I/II clinical trials. The Program Manager II serves as the primary liaison between clients, internal teams, and external vendors, driving program success from initiation through closeout. • Oversee drug substance and product development, analytical method development and validation, release and stability programs for IND-enabling and early-phase clinical studies. • Oversee manufacturing, packaging, labeling, storage, and distribution of clinical trial materials, ensuring supply continuity. • Ensure compliance with cGMP and ICH guidelines. Oversee technical investigations, change controls, and deviations for all program-related activities. • Identify and mitigate risks across the drug development spectrum—from formulation challenges in novel compounds to procurement constraints for commercial products. • Coordinate with external partners for manufacturing and testing activities, holding them accountable. • Develop budgets, monitor and control costs, negotiate scope changes, track milestones, and ensure the timely submission of high-quality deliverables. Qualifications • Advanced degree (Ph.D. or M.S.) in Pharmaceutical Sciences, Chemistry, or a related scientific discipline • Minimum of 7 years (Ph.D.) or 10 years (M.S.) of relevant experience • Strong knowledge of FDA cGMP regulations and FDA and ICH guidelines. • Proven experience managing complex projects and overseeing external vendors. • Excellent leadership, organizational, and communication skills. • Ability to travel as required (approx. 5%). Requirements • Project Management Professional (PMP) Certification • Prior work experience with a contract research organization (CRO) or contract development manufacturing organization (CDMO) • Experience working on U.S. government-funded contracts (e.g., NIAID, NCI, NCATS). • Strong publication record or history of technical presentations in the field of drug development. Benefits • Comprehensive health and life insurance • Disability coverage • Gym reimbursement • Mental health support • Paid holidays and PTO Apply tot his job