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Company

GE HealthCare · 1 day ago

Senior CMC Project Manager

United States

Full-time

Remote

Senior Level, Lead/Staff

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AppsHealth Care

Growth Opportunities

H1B Sponsor Likely

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Responsibilities

Build robust CMC development strategy and project plans together with your key stakeholders.

Lead your global CMC development team(s) working on new in-vivo diagnostic pharmaceuticals, to pre-clinical and clinical studies and into commercial manufacturing.

Be the CMC representative in cross-functional global Program Teams, to successful develop diagnostic imaging agent.

Provide CMC pharmaceutical development expertise as well as effective project management for your projects across all development stages and global applications.

Proactively identify risks, lead mitigation actions, and escalate to functions & senior management where appropriate.

Author and Review CMC modules for IND/IMPD/NDA submissions. Quality Expert role for Marketing Authorization applications and major variations.

Contribute to continuous improvement activities and implementation of LEAN tools across CMC development teams.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

/MSc in PharmaceuticsPharmaceutical industry experienceCMC developmentIND/IMPD/NDA submissionsEnglish communication skillsProject management skillsNetworking skillsLEAN tools implementationPET radiopharmaceuticals

Required

PhD/MSc in Pharmaceutics, Biotechnology, Chemistry, or similar.

Significant experience from pharmaceutical industry.

CMC development of drug substance and drug product including contributions to IND/IMPD/NDA submissions.

Strong scientific background, clear thinking, ability to define solutions to complex issues and identify efficient ways of working.

Strong interpersonal and leadership skills. Able to motivate and convince others while also being able to listen and consider other perspectives.

Strong English communication skills.

Preferred

Professional experience in CMC development of (PET) radiopharmaceuticals.

Established project management skills and certifications.

Builds wide and effective networks of contacts inside and outside the organization.

Openly shares information to solve problems with others.

Benefits

Competitive compensation and benefits

Good work-life balance and good atmosphere at work

Company

GE HealthCare

Glassdoor

4.2

GE Healthcare provides a wide range of medical technologies and services to healthcare providers and researchers. It is a sub-organization of General Electric.

Founded in 1892

Chicago, Illinois, USA

10,001+ employees

http://www.gehealthcare.com

H1B Sponsorship

GE HealthCare 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

2023 (1)

2021 (1)

2020 (3)