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MRIGlobal · 22 hours ago

Program Manager (Pharmaceutical Supply Chain and CMC)

North Kansas City, MO

Full-time

Onsite

Senior Level

$117K/yr - $138K/yr

7+ years exp

MRIGlobal is an independent scientific research organization dedicated to benefiting society through science and engineering. They are seeking a Program Manager specializing in oversight of client-sponsored investigational and clinical studies, focusing on the strategic management of drug development and supply chain solutions.

BiotechnologyEducationGovernment

H1B Sponsor Likely

Responsibilities

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

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

Qualification

Pharmaceutical SciencesDrug DevelopmentCMC RegulationsProject ManagementAnalytical ChemistryVendor ManagementRegulatory SubmissionsSupply Chain ManagementMicrosoft OfficeGLP RegulationsPMP CertificationLeadership SkillsOrganizational SkillsCommunication SkillsTechnical Presentations

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

Comprehensive coverage for you and your family

Resources that support mental, physical, social, and financial well-being

Wellness benefits like virtual coaching

No-cost counseling

Onsite health screenings

Gym reimbursement

Award-winning employer retirement matches

No-cost financial education benefits

Paid Parental Leave

PTO

Tuition reimbursement option to pay for higher education

Company

MRIGlobal

MRIGlobal is an independent organization performing research for government & industry on contract basis.

Founded in 1944

Kansas City, Missouri, USA

201-500 employees

http://www.mriglobal.org

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)