Senior CMC Project Manager

Job Description SummaryAs Senior CMC Project Manager, you will provide your Project Management and Chemistry, Manufacturing and Controls (CMC) expertise and lead teams developing our growing portfolio of diagnostic imaging agents.

Job Description

GE HealthCare is a leading global medical technology and digital solutions innovator with over 100 years of healthcare industry experience and around 50,000 employees globally. We enable clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by our Edison intelligence platform. We operate at the center of an ecosystem working toward precision health - digitizing healthcare, helping drive productivity and improving outcomes for patients, providers, health systems and researchers around the world.

Essential 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.

Qualifications/Requirements

• 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.

Desired Characteristics/Skills

• 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

What we offer:

• Stability and a chance to grow within a globally recognized company

• Learning and development, growth within a new team

• Competitive compensation and benefits

• Good work-life balance and good atmosphere at work

GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability or other characteristics protected by law.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.

#LI-Hybrid

#LI-AGN

Additional Information