MRIGlobal · 8 hours ago
Program Manager (Pharmaceutical Supply Chain and CMC)
MRIGlobal, 1222 Ozark Street, North Kansas City, Missouri, United States of America
Full-time
Onsite
Mid, Senior Level
$117K/yr - $138K/yr
7+ years expMRIGlobal is an independent scientific research organization dedicated to benefiting society and fostering a safe, healthy, and sustainable environment. They are seeking a Program Manager specializing in oversight of client-sponsored investigational and clinical studies, who will act as the technical and operational lead for Phase I/II studies and manage complex logistics and supply chain solutions.
BiotechnologyEducationGovernment
Responsibilities
Serve as the first line of defense in reviewing technical data
Ensure 100% continuity of supply for ongoing clinical trials by managing inventory against complex, shifting clinical protocols
Ensure all CMC and supply chain documentation is technically sound, audit-ready, and supports regulatory filings (IND)
Act as the primary point of contact for investigators and clients, translating complex issues into clear, actionable project updates
Lead the project management of custom manufacturing campaigns for Drug Substance (API) and Drug Product, utilizing your technical background to drive vendor accountability during formulation development, scale-up, and analytical validation
Manage the procurement strategy for commercial pharmaceutical products when required by the protocol
Facilitate technical review of batch records, analytical specifications, and release documentation in collaboration with Quality Assurance (QA)
Review and provide input on technical reports and CMC sections for regulatory submissions (IND), ensuring scientific accuracy whether the product is novel or repurposed
Create and maintain integrated project plans, tracking CMC milestones against clinical development timelines
Translate clinical protocols into concrete packaging and labeling strategies, ensuring blinding integrity and randomization compliance
Oversee the end-to-end execution of drug allocation
Monitor stability data in real-time to manage expiry dating and re-test periods for inventory across the network
Oversee global logistics and cold chain requirements, troubleshooting temperature excursions based on stability data
Lead internal technical meetings and client-hosted updates
Manage the program budget, including technical scope reviews and change order negotiation with vendors
Accountable for the timely submission and quality of all program deliverables, ranging from technical manufacturing reports to monthly status updates
Exercise functional authority over multidisciplinary project teams (chemists, analysts, technicians, QA, etc.)
Serve as the technical liaison for CDMO partners, holding them accountable to Quality Agreements and timelines
Qualification
Required
PhD or MS in Pharmaceutical Sciences, Chemistry, Pharmacy, or a closely related technical field
A minimum of 7 years (PhD) or 10 years (MS) of relevant experience in drug development, pharmaceutical operations, or CMC
Demonstrated experience leading scientific projects, managing timelines, or overseeing external vendors/CDMOs
Working knowledge of cGMP regulations and ICH guidelines. Familiarity with FDA GCP regulations is a plus
Deep understanding of drug substance/drug product manufacturing, analytical chemistry, stability testing, and clinical trial materials management
Strong leadership, organizational, and project management skills
Proficient in the use of Microsoft Word, Excel, PowerPoint, Outlook, and Teams and the ability to learn new software and systems
Ability to travel as needed (5%)
Preferred
Strong publication record or history of technical presentations in the field of drug development
Familiarity with GLP: Understanding FDA GLP regulations (21 CFR Part 58) as they relate to the transition from pre-clinical to clinical development
Project Management Professional (PMP) Certification
Experience managing US government contract work
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
MRIGlobal
MRIGlobal is an independent organization performing research for government & industry on contract basis.
201-500 employees
H1B Sponsorship
MRIGlobal has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (1)
Funding
Current Stage
Growth StageLeadership Team
Marty Nevshemal
Chief Financial Officer & Treasurer
Melissa Meyer, PACE
C-Level Sr. Executive Assistant To The President & CEO, COO & CIO
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