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MRIGlobal · 2 weeks ago

Program Manager II – Pharmaceutical Development & Clinical Supply

Kansas City, MO

Full-time

Hybrid

Mid, Senior Level

$128K/yr - $141K/yr

7+ years exp

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.

BiotechnologyEducationGovernment

H1B Sponsor Likely

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

Qualification

Pharmaceutical SciencesFDA cGMP regulationsProject ManagementAnalytical method developmentVendor managementRisk managementPMP CertificationCRO experienceGovernment contracts experienceLeadership skillsOrganizational skillsCommunication skillsTechnical presentations

Required

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%)

Preferred

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

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)