At a Glance
- Tasks: Lead the development of APIs and collaborate with external partners to ensure quality and compliance.
- Company: Join GE HealthCare, a global leader in medical technology and innovation.
- Benefits: Competitive salary, flexible work locations, and opportunities for career growth.
- Other info: Work in a diverse environment that values integrity, collaboration, and innovation.
- Why this job: Make a real impact in healthcare by developing life-changing pharmaceutical solutions.
- Qualifications: PhD or MSc in relevant fields with experience in API development and stakeholder management.
The predicted salary is between 51750 - 63250 £ per year.
As API Lead, you provide technical leadership for the development and manufacturing of precursors and active pharmaceutical ingredients (APIs) through external Contract Manufacturing Organizations (CMOs). You lead activities from early development and process optimization through scale-up, technology transfer, GMP manufacturing, to late-stage development. As the primary technical interface between internal project teams and external partners, you ensure that quality, timelines, risks, costs, and technical deliverables remain aligned. You apply your expertise in synthetic chemistry, GMP, and regulatory CMC requirements to guide technical decisions and resolve complex development and manufacturing challenges. Through strong stakeholder management, you bring internal and external experts together to deliver robust and compliant API manufacturing solutions.
Ideally this role is based in Oslo, where the team is based. However, we offer flexibility, and the role can also be based at our sites in the Netherlands (Eindhoven), or UK (Pollard Wood).
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 the development and manufacturing of APIs, precursors, and key materials at external CMOs from early development through commercialization.
- Act as the primary technical interface between internal project teams, CMOs, key suppliers, and other external development and manufacturing partners.
- Define development strategies, deliverables, timelines, risks, and priorities, and oversee process development, optimization, scale-up, technology transfer, and GMP manufacturing.
- Contribute to assessing selecting, qualifying, and onboarding CMOs and key suppliers based on technical capabilities, capacity, quality, cost, timelines, and risk, and monitor ongoing performance.
- Lead technical, quality, and manufacturing challenges, including deviations, investigations, change controls, and impurity-related issues.
- Define API starting material, characterization, and impurity-control strategies, including regulatory justification in line with applicable ICH guidelines.
- Prepare and review CMC documentation for manufacturing activities, and regulatory submissions.
- Collaborate across Quality, Regulatory, Analytical Development, Manufacturing, Supply Chain, Sourcing, IP, Legal, and project teams to ensure compliant execution in line with applicable GMP, regulatory, quality, and EHS requirements.
Basic Qualifications and Requirements
- PhD or MSc in Organic Chemistry, Pharmaceutical Chemistry, Chemical Engineering, or a related scientific or engineering discipline.
- Relevant experience in API, precursor, or pharmaceutical process development, including process development, scale-up, technology transfer, or manufacturing.
- Demonstrated experience managing CMOs or outsourced pharmaceutical development and manufacturing activities.
- Strong knowledge of GMP requirements, pharmaceutical development, and regulatory CMC expectations.
- Strong technical understanding of API characterization, analytical method development, impurity investigations, and impurity-control strategies.
- Experience preparing or supporting CMC documentation for regulatory submissions and health-authority interactions.
- Excellent written and verbal communication and stakeholder-management skills, with the ability to influence decisions and manage competing priorities in cross-functional and multicultural environments.
- Fluent in English, both written and verbal.
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.
API Lead employer: GE Healthcare
GE Healthcare is an exceptional employer, offering a dynamic work environment where innovation meets purpose in the North East of England. With a strong focus on employee growth and collaboration, we provide comprehensive benefits and a culture that values every voice, ensuring that our team members can thrive while making a meaningful impact in healthcare. Join us to unlock your ambition and contribute to a healthier world through cutting-edge medical technology.
StudySmarter Expert Advice🤫
We think this is how you could land API Lead
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like GE Healthcare. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like GE Healthcare.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like GE Healthcare. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what GE Healthcare is looking for. A tailored application can really make you stand out!
We think you need these skills to ace API Lead
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at GE Healthcare!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show GE Healthcare that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at GE Healthcare!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At GE Healthcare, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at GE Healthcare
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at GE Healthcare that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with GE Healthcare’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
