FUJIFILM Diosynth Biotechnologies

Analytical Project Coordinator for Method Transfer in Quality Control

Hillerod Full time

Join Our Team as an Analytical Project Coordinator for Method Transfer in Quality Control


Are you passionate about project coordination, experienced in Method Tech Transfer, and eager to contribute to a rapidly evolving Contract Development and Manufacturing Organization (CDMO)? We offer a thrilling and challenging role in a company positioned for a dynamic future, with numerous partners and products. Discover excellent opportunities for personal growth and development with us!

About the Role
At our Hillerød site, our Quality Control (QC) Department consists of approximately 260 dedicated employees divided across Analytical Development Teams, Testing Teams, and Support Teams.
You will be part of the QC Projects Team in the Analytical Development Department. The team consists of eight highly skilled and dedicated colleagues. 
As an Analytical Project Coordinator, you will focus on Drug Substance (DS) and Drug Product (DP) methods, playing a vital role in implementing test methods to support full-scale testing for engineering batches, clinical phase III trials, and PPQ technology transfer programs. Our dynamic environment supports biologics DS/DP production and the global release of commercial products for our clients.

Key Responsibilities
•    Coordinate method transfer activities across QC laboratories, customer relations, and contract organizations.
•    Lead meetings with customers and internal teams to ensure timely prioritization of both non-compendial and compendial method transfers.
•    Develop transfer plans, transfer summary reports, and manage change control for method transfers.
•    Review protocols and reports on transfer, validation, and qualification.
•    Optimize Tech Transfer projects through proactive project management and effective stakeholder collaboration.

Your Profile
 

Qualifications:
•    Master's degree in Pharmaceutical Sciences, Biochemistry, Biology, or related field.
•    Experience with cGMP QC laboratory practices and ICH guidelines.
•    Strong scientific expertise and experience in method transfer and validation.
•    Proven skills in project coordination/management with client/customer experience.
•    Excellent stakeholder management and adaptability.
Personal Attributes:
•    Self-driven, systematic, and skilled in structured project planning.
•    Solution-oriented and collaborative, with an openness to change.
•    Energetic, flexible, and equipped with a sense of humor.
•    Passionate about learning and sharing knowledge.
•    Fluent in English, both written and verbal.
•    Welcoming working-from-home on a regularly base.

About the QC Department
In QC, we strive towards a OneQC team spirit, where we help and support each other across teams—not only to reach our goals but also to foster a high level of collaboration and opportunities for personal development. The pillar of our QC department is our employees; our success is possible only because of competent and dedicated colleagues who want to make a difference for QC, our site, our customers, and patients all over the globe. As a leading CDMO company, we in QC are committed to continuously improving our ways of working, creating a dynamic and inspiring environment with significant individual decision-making due to our flat organizational structure.

About the QC AD Department
The QC AD Department is composed of a Projects Team, a Chemistry Team, a Bioassay Team, and a TOC & Drug Product (DP) Team, totaling around 50 members. These teams support non-GXP sample testing from our Process Specialist, Manufacturing Science and Technology, and Drug Substance and Drug Product Teams. We work in close collaboration with QC Testing teams and lead method validation, qualification, and transfer studies to enable in-process and release testing of Drug Substance and Drug Product Manufacturing.
Over the past four years, our site has experienced significant growth as a CDMO, integrating numerous new clients and implementing methods essential for testing their products. With this rapid expansion and increased complexity, we are committed to elevating our department to the next level. This involves adopting smarter, more efficient practices and investing time in optimizing processes and procedures. Our focus remains on continuous improvement to meet evolving demands and ensure excellence in our operations.

About FUJIFILM Biotechnologies
At FUJIFILM Biotechnologies, we advance tomorrow’s medicines. Our culture prioritizes people, offering competitive salaries, health benefits, and opportunities for remote work. Enjoy perks like a mobile barista, Friday brunch, and “bell ringing” traditions for milestone achievements. Embrace a balanced work-life while joining an international team committed to excellence.

Application Process
Has this opportunity sparked your interest? Submit your CV and cover letter promptly. For inquiries, contact Solveig Vibe, Manager of QC Projects Team in AD, at Solveig.Vibe@fujifilm.com. Interviews will be held continuously, and the position will be closed upon finding the right candidate. Please expect potential delays during vacation periods.

Join us for a promising career in a vibrant, inspiring environment at FUJIFILM Biotechnologies!

The Company

FUJIFILM Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark, Teesside, UK, RTP, North Carolina and College Station, Texas, USA. We use our skills, dedication, and ambition to enable impact for the world’s most innovative biotech and biopharma companies reimagining healthcare’s potential. We work across the entire lifecycle of our customers’ products – enabling success throughout. Every cure, vaccine, biologic, and advancement we contribute to starts with our people and our passion. We fuel one another’s passion, help accelerate progress, expand capabilities, strengthen innovation, and improve processes to improve lives.

We offer the chance to be part of a global workplace where passion, drive and commitment are met with opportunities for professional and personal development. Deeply committed to diversity and inclusion, we ensure that everyone no matter their background or gender has an opportunity to develop. We take pride in enriching our communities, caring for our environment, and cultivating a world of opportunity for future generations.

We aim to foster a collaborative, innovative and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values. We pursue our fullest potential as individual contributors and team members. We strive to be the employer of choice and offer a competitive compensation and benefit package.

FUJIFILM Biotechnologies Denmark (FLBD) 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.