Senior QC Project Coordinator, Quality Control

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients lives by bringing new biopharmaceuticals to market.

Join AGC Biologics as a QC Project Coordinator Drive Innovation in Biopharmaceutical Quality Control

Are you an experienced professional with a passion for coordinating analytical activities and leading projects in a dynamic international environment Do you thrive in cross-functional roles that bridge technical expertise project management and regulatory compliance If so we invite you to explore this exciting opportunity to join our Quality Control (QC) team as aQC Project Coordinator.

About the Role

As a QC Project Coordinator you will play a pivotal role in ensuring the seamless execution of QC activities that support clinical and commercial manufacturing. Acting as the key link between QC teams external customers and internal stakeholders you will drive progress ensure compliance and deliver results that meet the highest standards of quality and efficiency.

This is more than a coordination roleits an opportunity to lead strategize and contribute to the success of cutting-edge biopharmaceutical projects. You will represent QC in customer and core project teams lead cross-functional analytical teams and provide strategic input to optimize processes and ensure regulatory compliance.

Why Join Us

At AGC Biologics we are committed to innovation collaboration and excellence in biopharmaceutical manufacturing. As part of our QC Chemistry Department you will work alongside talented professionals in a fast-paced supportive environment that values your expertise and contributions. You will have the opportunity to:

• Lead impactful projectsthat shape the future of biopharmaceutical production.
• Collaborate globallywith internal teams customers and external partners.
• Grow professionallythrough exposure to diverse challenges and opportunities for process improvement.

Key Responsibilities

• Project Leadership:Represent QC in customer and core project teams acting as the single point of contact for QC-related matters. Lead cross-functional QC analytical project teams to drive progress and meet milestones.
• Analytical Coordination:Oversee method validations transfers and batch release schedules. Collaborate with QC subject matter experts to ensure timely execution.
• Documentation and Compliance:Write review and approve GMP documentation including CAPAs deviations CoAs and change control cases.
• Strategic Input:Advise management on QC-related matters contribute to process optimization and establish/update specifications for Drug Substance and Drug Product.
• Regulatory Support:Participate in regulatory inspections (e.g. DMA FDA) and customer audits.
• Relationship Building:Foster strong communication and collaboration across departments with customers and external partners.

Your Profile

We are seeking an experienced candidate who brings a blend of technical expertise project management skills and a proactive mindset. The ideal candidate will have:

• Educational Background:MSc in Chemistry Biochemistry or a related field with 26 years of relevant experience; or PhD with 3 years of relevant experience.
• Project Management Expertise:Proven ability to manage multiple projects oversee milestones and drive coordination across stakeholders.
• GMP Knowledge:Hands-on experience working in cGMP settings under EU and US regulatory guidelines.
• Communication Skills:Strong interpersonal skills to build relationships and effectively communicate with internal and external stakeholders.
• Language Proficiency:Fluency in English (written and spoken). Interest in learning Danish is an advantage.

What We Offer

• A dynamic and collaborative work environment that values innovation and teamwork.
• Opportunities to lead impactful projects and contribute to the success of global biopharmaceutical manufacturing.
• Professional growth through exposure to diverse challenges and opportunities for process improvement.
• Competitive compensation and benefits package.

Ready to Make an Impact

If you are an experienced professional looking for a challenging and rewarding role in biopharmaceutical quality control we encourage you to apply. Join us at AGC Biologics and be part of a team that is shaping the future of medicine.

Our culture at AGC Biologics is defined by the six core values: Knowledge Trust Quality Ingenuity Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins plasmid DNA (pDNA) messenger RNA (mRNA) viral vectors and genetically engineered cells. Our global network spans the U.S. Europe and Asia with cGMP-compliant facilities in Seattle Washington; Boulder and Longmont Colorado; Copenhagen Denmark; Heidelberg Germany; Milan Italy; and Chiba Japan. We currently employ more than 2500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients most complex challenges including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more visit.Want to keep posted about our growth and learn more about our company Follow us on LinkedIn and give us a quick Like on Facebook!

AGC Biologics offers a highly competitive compensation package and a friendly collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age ancestry color family or medical care leave gender identity or expression genetic information marital status medical condition national origin physical or mental disability political affiliation protected veteran status race religion sexual orientation or any other characteristic protected by applicable laws regulations and ordinances.