What are the responsibilities and job description for the CMC Project Manager position at Monopar Therapeutics Inc.?
Monopar is a growing biotech company seeking a bright, motivated, and collaborative CMC Project Manager to support the company’s radiopharmaceutical and rare disease pipeline. We have exciting, clinical-stage novel radiopharmaceuticals and a late-stage rare disease candidate. You will join a small, talented team and will have significant opportunities for impact and growth.
What you’ll do…
- Contribute to advancement of Monopar’s cutting-edge radiopharmaceutical development programs
- Responsibilities will include chemistry, manufacturing and control (CMC) projects to drive preclinical and clinical development of Monopar’s drug pipeline
- Support project management for Phase 1 and compassionate use drug manufacturing, analytical, and supply in collaboration with external vendors
- Develop and maintain detailed project schedules, track milestones, ensure deadlines are met and create comprehensive work plans
- Coordinate with internal teams and external vendors to project and monitor progress, ensuring effective communication and collaboration
- Organize and schedule meetings to support CMC activities
- Oversee inventory management, logistics, and timely delivery of drug products to clinical sites
- Lead the maintenance of project documentation, including reports, technical documents, communications, project status updates for pre-clinical and clinical studies, and assist in preparation of project status reports, manufacturing procedures and R&D study reports
- Effectively communicate project-related information including the planning, creation and maintenance of key metrics (e.g., timelines, deliverables, budgets)
- Contribute to assisting in regulatory filings (e.g., IND / IMPD / CTN, NDA)
- Work in an office (Wilmette, IL north of Chicago) with a dynamic, talented team
What skills & experience you’ll bring to us…
- Bachelor’s or master’s degree in a scientific discipline (e.g., Biology, Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related field). A background in radiopharmaceuticals or life sciences is a plus
- Experience in managing or supporting pharmaceutical development related projects, including familiarity with R&D operations, project management, or radiopharmaceuticals. Internships or academic research experience in CMC-related fields are also considered valuable
- Proactive learning attitude with a demonstrated ability to adapt to new challenges and evolving CMC project needs
- Strong organizational abilities with a proven track record in managing multiple tasks simultaneously, prioritizing effectively and is proactive in managing project timeline
- Excellent communication (oral and/or written) skills to facilitate clear and effective communication with internal teams and external partners
About Monopar Therapeutics
Monopar Therapeutics (NASDAQ:MNPR) is a clinical-stage biotechnology company developing novel radiopharmaceuticals for oncology and a new treatment for Wilson Disease, a rare genetic disorder. Its pipeline includes radiopharmaceuticals targeting advanced solid tumors and late-stage ALXN1840, a treatment for Wilson Disease. The radiopharma programs target advanced cancers and include Phase 1 MNPR-101-Zr for imaging, and Phase 1 MNPR-101-Lu and late-preclinical MNPR-101-Ac for therapy.
