GMP Process Lead

We are looking for new team members to join our dedicated FGM Operations Support team and play a vital role in maintaining GMP compliance while driving continuous improvement initiatives to achieve operational excellence.

As we are embarking on a great journey of expanding our Finished Goods Manufacturing (FGM) capabilities and partnering with new and exciting customers, we hope you will join us as our new GMP Process Lead colleague!

Your New Role
You will be facilitating, coordinating, and defining structures, to ensure completion of the cases and projects. The responsibilities within this job will give you the opportunity to achieve great ownership of the processes and develop informal leadership skills.

Your daily tasks

• Facilitate task forces, investigations, and systematic problem-solving initiatives to enhance operational efficiency and address critical issues promptly.
• Drive continuous improvement projects aimed at enhancing operational efficiency, reducing waste, and optimizing processes within the FGM Operations Support team and Shop floor.
• Ensure audit and inspection readiness, coordinating on behalf of Finished Goods Management (FGM).
• Collaborate with cross-functional teams to identify opportunities for operational enhancements and drive initiatives to achieve organizational objectives.
• Provide leadership and guidance to team members, fostering a culture of continuous improvement and accountability.
• Engage in interactions with customers.

Skills & Talents, we hope you possess

• A bachelor’s degree in, Manufacturing Engineering, Pharmaceutical Sciences, or a related field, providing a solid foundation for understanding GMP principles and practices.
• Proven experience in a GMP-regulated environment, with a strong understanding of regulatory requirements and quality standards. Preferably from a Finished Goods Assembly, Labelling and Packaging area.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with diverse stakeholders. (Communication in both English and Danish is required)
• Leadership capabilities, including the ability to motivate and inspire teams to achieve goals.
• Analytical mindset with the ability to identify root causes of operational challenges and implement effective solutions.
• Detail-oriented mindset with a passion for ensuring compliance and upholding the highest standards of quality in all operational activities.

We hope you are
Curious of nature and meet and greet people with a smile and have a can-do attitude. You work with humility and respect for the people around you.

Your New Team of Specialists
The Operations support team consists of 7 highly skilled individuals supporting FGM with a mixture of process, equipment, and GMP knowledge. We are dedicated to supporting each other and collectively owning GMP compliance.

We engage in a wide range of responsibilities and tasks, contributing to a dynamic and challenging work environment. You will work in very close collaboration with the colleagues on the FGM shop floor, but also across the organization – Manufacturing Science, Maintenance and Quality among others. We aim to always be curious about the current processes and strive to make an impact on how to work even smarter in the Finished Goods Manufacturing Area

We are team players and people who like details without losing sight of the big picture. The work environment is international. We keep a high pace and focus on a vital work life balance while having fun. We put a strong emphasis on psychological safety through trust and empowerment within our teams and hope that this is something that speaks to you as well.

Application
Has this sparked your interest? Then please apply now and be part of our mission to deliver high-quality products to our Partners and Patients worldwide.

Please upload your CV and cover letter as soon as possible as we screen candidates on a continuous basis. For questions, please contact Manager Tinna Buhl phone +45 28101491

FUJIFILM Diosynth Biotechnologies is a world leading Contract Development Manufacturing Organization (CDMO) serving customers in the pharmaceutical industry – from pre-clinical investigations to commercial GMP production. Our overall mission is to “Advancing Tomorrow’s Medicines” and we like to invite you to be part of our journey.

The work we do at FUJIFILM Diosynth Biotechnologies (FDB) has never been more important—and we are looking for talented candidates to join us. We’re growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you, who want to make a real difference in people’s lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe.

Our Manufacturing site in Hillerød, Denmark, brings together a complete range of expertise, capabilities, and technologies to manufacture advanced biologics. As we continue to enhance and expand our capabilities, we are looking for people who share our passion, drive, and energy – what we call Genki – to join our team.

FUJIFILM Diosynth Biotechnologies Denmark (FDBD) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identify or any other protected class.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

Location: FDBD Hillerod