Tech Transfer Leader, R&D PET Clinical Manufacturing

Job Description SummaryGE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter.

The Pharmaceutical Diagnostics division provides & innovates in new molecular imaging products in neurology, oncology and cardiology. We have a solid and growing pipeline and need to build our team. This role provides scientific and operational oversight over new technology transfer projects into our manufacturing network. The role will lead the collaboration with external partners across with the internal scientific subject matter expert team, for technology transfer as well as ongoing clinical manufacturing. The role will ensure delivery of quality products and data in line with all quality and regulatory requirements.

Our Pharmaceutical Diagnostics (PDx) business is the number one global supplier of contrast media and molecular imaging agents used to enhance medical imaging exams. Used throughout all major disease area diagnostic and treatment pathways, PDx products support three patients every second around the world.

Job Description

Roles and Responsibilities

• As the team member implementing tech transfers, be a positive representative of the PDx PET R&D team to customers and partners in the field.
• In partnership with the subject matter experts (SMEs)of the Project Chemistry, Manufacturing & Controls Development team, lead technology transfer project to set up for clinical manufacturing.
• Close collaboration with clinical development team to align, plan and deliver to the given clinical studies.
• Accountable for the tech transfer and clinical manufacturing for given PET contract manufacturing organizations (CMOs).
• Lead cross-functional team to set up, define clear roles and responsibilities with external partners and internal team.
• Ensure that the transfer process is effectively managed, monitored and reported to stakeholders. Responsible for managing relations with the CMOs, internal and external stakeholders.
• The primary contact person with the PET Manufacturing Site during the Technology Transfer, and during clinical manufacture Technical capability of PET radiopharmaceutical clinical manufacturing, including quality control. Lead resolution of issues / technical queries with SMEs.
• Provide expertise to R&D projects in development, including contributing to regulatory documentation and development strategies.
• Organize documentation review and approvals. Leads and actively participates in continuous improvement projects.

Required Qualifications

• Bachelors in  Chemistry, Pharmaceutical sciences or related field.
• Solid relevant experience required, minimum 3 years.
• Experience with PET/Radiopharmaceutical manufacturing, research or development.
• Experience operating HPLC, GC, TLC, and preparing reagents and solutions
• Strong documentation skills 
• Organized, clear thinking, ability to identify smart/creative solutions to problems
• Have the ability to work in a dynamic, time-sensitive environment and prioritize work as assigned.
• Be able to work in locations where PET radiopharmaceuticals are manufactured.
• Highly motivated and self-directed, detail-oriented, and schedule-driven
• Ability to work across time zones and cultures.
• Ability to obtain or maintain a passport
•  travel expected. (up to  40%)

Desired Characteristics

• PET F18 and Ga68 radiopharmaceutical experience
• Well versed in GMP requirements
• Builds wide and effective networks of contacts inside and outside the organization.
• Documented Project Management Skills
• Familiar with Lean toolbox

For U.S. based positions only, the pay range for this position is $97,600.00-$146,400.00 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 Information

GE 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

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