GE HealthCare Tech Transfer Leader R&D PET Clinical Manufacturing 

Remote, Remote 

68110865

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.
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