Responsibilities:
Develop and improve technology transfer and site qualification documentation.Organize and lead internal and external meetings in support of projects Oversee transfer of automated manufacture and QC release testing of PET radiopharmaceuticals external manufacturing sites.Support GMP site set-up of PET radiopharmaceutical production and provide site management support as required.Strong customer focus. Good understanding of external partners technical capabilities and process work-flows including quality, EHS and facility infrastructure/equipment set-up.Project management oversight of new CMOs to meet project timelinesOngoing support and project management of CMO operationsInterface with GEHC Quality Assurance on CMO remediation activitiesAssist in the design of product development activitiesDeployment of product updates and enhancementsReview of site data to ensure accuracy for relevant regulatory submissions and filings Travel may be required within North and South America (up to 15%)Qualifications:
Bachelor’s degree in chemistry / chemical engineering or similar scientific discipline5 years of experience working in the pharmaceutical industry (manufacturing, R&D, or technical support).Demonstrated ability to lead programs and develop teams.Demonstrated ability to identify and implement Best Practices and deal with high levels of ambiguity.Demonstrated ability to work cross-functionally and fulfill company priorities.Preferred Qualifications:
Experience in PET tracer manufacture (cyclotrons, chemistry systems platforms, QC methodology) is highly desirable.MS in Chemistry or Life Sciences with at least 10 years’ experience in a pharmaceutical environment and at least 5 years’ experience in GMP radiopharmaceutical manufacturing and/or development.Worked in a GMP environment. Has product quality or supply chain experience. Exposure working to regulatory standards.The successful individual will have a strong knowledge of PET Radiopharmaceuticals and previous experience with CMOs and have a high level of technical expertise. Good knowledge of radiochemistry techniques and applications including automated synthesizers and QC analytical techniques. Strong interpersonal skills, problem solving, and an ability to work constructively with internal and external customers will be critical to the success of the product development and commercialization. The successful individual will also be expected to work independently on behalf of the core team, as well as lead, initiate and/or provide major innovative scientific input in the identification of new automated methodologies/radiotracer synthesis within.
About Us
With 4000+ employees serving 100+ countries, GE Healthcare’s Pharmaceutical Diagnostics (PDx) business is the number one global supplier of contrast media and molecular imaging agents used in medical imaging exams to improve the visibility of organs, blood vessels or tissues, often helping radiologists distinguish between normal and abnormal conditions. PDx products makes a huge impact worldwide - supporting three patients every second.
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.
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Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.
For U.S. based positions only, the pay range for this position is $93,840.00-$140,760.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.Additional InformationGE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: No
Application Deadline: October 03, 2024