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Manufacturing Development Scientist

GE HEALTHCARE -
Cork, County Cork

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Job details

Qualifications

Doctoral degree
Chemical Engineering
Master's degree
Analysis skills
Product development
Cleaning
Chemistry
Root cause analysis

Full job description

Job Description Summary

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.

Job Description

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.

Essential Responsibilities

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.

Basic Qualifications and Requirements

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 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.

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.

#Onsite

#LI-WRO

Additional Information

Relocation Assistance Provided: No

Apply Now

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