[Remote] Program Manager II – Pharmaceutical Development & Clinical Supply

Note: The job is a remote job and is open to candidates in USA. MRIGlobal is an independent scientific research organization dedicated to benefiting society through science and engineering. The Program Manager II will lead cross-functional programs in pharmaceutical development and clinical supply chain operations, ensuring compliance and driving program success from initiation through closeout. Responsibilities • 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 (e.g., securing single-lot bulk supply and managing expiration dating of commercial stock)—before they impact clinical timelines • 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. Lead internal technical meetings and client-hosted updates Skills • 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%) • 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 • Health and life insurance • Disability coverage • Gym reimbursement • Mental health support • Paid holidays • PTO • Wellness benefits like virtual coaching • No-cost counseling • Onsite health screenings • Award-winning employer retirement matches • No-cost financial education benefits • Paid Parental Leave • Tuition reimbursement option Company Overview • MRIGlobal is an independent organization performing research for government & industry on contract basis. It was founded in 1944, and is headquartered in Kansas City, Missouri, USA, with a workforce of 201-500 employees. Its website is Company H1B Sponsorship • MRIGlobal has a track record of offering H1B sponsorships, with 1 in 2020. Please note that this does not guarantee sponsorship for this specific role. Apply tot his job