Manufacturing Development Scientist

As a Manufacturing Development Scientist you will provide scientific and technical expertise to support the development scale-up and lifecycle management of manufacturing processes across the Pharmaceutical Diagnostics (PDx) portfolio. You will contribute to New Product Introduction (NPI) readiness and lifecycle product changes by executing manufacturing strategies aligned with CMC and regulatory requirements. Working cross-functionally with Manufacturing Quality Regulatory Affairs and R&D teams you will enable robust technology transfer process validation and continuous improvement. This role plays a critical part in ensuring reliable product supply compliance and delivery of high-quality medicines to patients globally. This role requires some travel to other PDx manufacturing sites primarily in Oslo and Ireland.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition turn ideas into world-changing realities and join an organization where every voice makes a difference and every difference builds a healthier world.

GE HealthCare Pharmaceutical Diagnostics (PDx) 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.

• Lead and document the development and optimization of robust scalable manufacturing processes contributing from development through preclinical and clinical phases to commercial manufacturing;
• NPI & Lifecycle Management: Provide hands-on-on manufacturing support for NPI and lifecycle changes;
• Technology Transfer & Scale-Up: Leader support document execution of technology transfers and process validation activities;
• Cross-Functional Collaboration: Collaborate with R&D Quality Regulatory and Manufacturing teams including Engineering and vendors to design and qualify equipment that fit for purpose and aligns with process needs;
• Process Monitoring & Continuous Improvement: Analyze data to improve process performance and robustness;
• Documentation & Regulatory Support: Prepare review and deliver suitable scientific documentation as subject matter experts to support regulatory submissions (IND IMPD NDA MAA etc.);
• Investigation & Problem Solving: Drive lead document deviations risk assessments GAP/ root cause analysis and CAPA implementation;
• Provide validation expertise prepare validation documentation including cleaning validation;

• Compliance & Quality: Ensure cGMP compliance and support audit readiness and follow up.

• MSc or PhD in Chemistry Chemical Engineering Pharmacy or related field;
• GMP pharmaceutical experience in drug product development drug product solutions drug product filling processes including inspection MSAT or technical operations;
• Knowledge of process development scale-up validation and CMC lifecycle;
• Self-driven independent strong analytical skills and ability to work in global matrix environments;
• Experience with CMOs Technical Transfer Regulatory submissions and Lean/Operational Excellence;
• Willingness to travel internationally (up to 25%).

Behaviors

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.

Total Rewards

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 youd expect from an organization with global strength and scale and youll be surrounded by career opportunities in a culture that fosters care collaboration and support.

Inclusion & Diversity

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 age disability protected veteran status or other characteristics protected by law.

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