Program Manager (Pharmaceutical Supply Chain and CMC Support)

Program Manager (Pharmaceutical Supply Chain and CMC Support)

MRIGlobal is seeking a highly motivated individual to join our Integrated Pharmaceutical Solutions Business Unit as a Program Manager (PM) specializing in oversight of client-sponsored investigational and clinical studies. This position is on-site at our headquarters in Kansas City, Missouri.

Summary of Role

Are you a scientist ready to apply your technical expertise to the strategic management of drug development?

MRIGlobal is seeking a scientist with project leadership experience to join our team as a Program Manager. This role is the strategic bridge between the laboratory and the clinic. Unlike a traditional project manager, you will rely on your scientific background to oversee the technical execution of CMC campaigns and the complex logistics of early-phase clinical supply.

You will act as the technical and operational lead for client-sponsored Phase I/II studies. Your portfolio will be diverse: one program may require overseeing the de novo synthesis of a novel compound, while another requires the strategic sourcing and blinding of commercial product for a new indication. You won't just track timelines; you will interpret technical and logistical risks and translate them into supply chain solutions. This is an ideal role for a seasoned professional who enjoys the rigor of science but prefers the broader scope of program management over day-to-day bench work.

Principal Accountabilities and Success Factors

• Technical Oversight: Serve as the first line of defense in reviewing technical data. Interpret and mitigate risks across the 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.
• Supply Chain Continuity: Ensure 100% continuity of supply for ongoing clinical trials by managing inventory against complex, shifting clinical protocols.
• Scientific Defensibility: Ensure all CMC and supply chain documentation is technically sound, audit-ready, and supports regulatory filings (IND).
• Client Stewardship: Act as the primary point of contact for investigators and clients, translating complex issues into clear, actionable project updates.

Essential Functions

CMC Project Management & Technical Support

• Novel Manufacturing Oversight: 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.
• Commercial Sourcing & Modification: Manage the procurement strategy for commercial pharmaceutical products when required by the protocol. Address challenges related to lot sequestration, chain of custody, and the technical requirements for modifying/blinding commercial dosage forms (e.g., over-encapsulation) to match placebo.
• Technical review: Facilitate technical review of batch records, analytical specifications, and release documentation in collaboration with Quality Assurance (QA).
• Regulatory Support: Review and provide input on technical reports and CMC sections for regulatory submissions (IND), ensuring scientific accuracy whether the product is novel or repurposed.
• Project Management: Create and maintain integrated project plans, tracking CMC milestones against clinical development timelines.

Clinical Supply Chain Operations

• Packaging & Blinding Strategy: Translate clinical protocols into concrete packaging and labeling strategies, ensuring blinding integrity and randomization compliance.
• Allocation Management: Oversee the end-to-end execution of drug allocation. Apply scientific precision to the validation of investigator requests and randomization codes, acting as the critical control point for inventory release.
• Stability & Expiry Management: Monitor stability data in real-time to manage expiry dating and re-test periods for inventory across the network.
• Logistics & Cold Chain: Oversee global logistics and cold chain requirements, troubleshooting temperature excursions based on stability data.

Cross-Functional Leadership

• Stakeholder Communication: Lead internal technical meetings and client-hosted updates.
• Financial Oversight: Manage the program budget, including technical scope reviews and change order negotiation with vendors.
• Deliverable Management: Accountable for the timely submission and quality of all program deliverables, ranging from technical manufacturing reports to monthly status updates.

Supervisory/Management Responsibilities

• Matrix Leadership: Exercise functional authority over multidisciplinary project teams (chemists, analysts, technicians, QA, etc.).
• Vendor Management: Serve as the technical liaison for CDMO partners, holding them accountable to Quality Agreements and timelines.

Minimum Qualifications

• 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 Qualifications

• 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.