Are you a skilled scientist eager to join a fast-growing CDMO? We are looking for a who shares our passion, drive, and energy – what we call Genki – to join QC Chemistry.
About FUJIFILM Biotechnologies and our Quality Control Department
FUJIFILM 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 that journey.
Our Quality Control (QC) department at site Hillerød consists of approximately 250 employees divided into different support teams and testing teams. 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 support a high level of collaboration and possibilities for personal development. The pillar in our QC department is our employees – our success is only possible due to competent and dedicated colleagues, who wants 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 obligated to continuously improve our way of working creating a dynamic and inspiring environment with huge individual co-decision making due to our flat organizational structure.
The culture at FUJIFILM Denmark (FDBD) is key if you ask our employees and besides a competitive salary and bonus package, we offer health insurance, massage and physiotherapy, health check, fitness center, possibility to work from home and most recently we invested in a mobile barista coffee van. FDBD also has a canteen arrangement incl. Friday brunch and monthly afternoon cake, just as we have a “bell ringing” tradition when reaching important milestones.
About the QC Chemistry Department
The QC Chemistry department comprises over 30 dedicated employees across three teams. We play a crucial role in supporting the global release of commercial products with a variety of chemistry methods, including purity and impurity evaluations and biologic Drug Substance (DS) manufacturing support We work with a wide variety of chemistry methods (e.g. CESDS, ICE, SDS-page, HPLC/UPLC, appearance, pH, osmolality, SoloVPE/UV). We also provide support to the biologic DS manufacturing by ensuring cleaning validation testing, and gas/water testing. Method transfers and method validation and qualification are becoming a key deliverable for the department with the many new customers due to the site expansion and establishment of a Fill & Finish facility for Drug Product (DP). Additionally, we perform qualifications of controls and reference standards, while managing deviations, CAPAs, invalid assays, OOS, and Change Controls, all integral to our daily operations to ensure timely delivery of commercial products to patients.
About the Position
In this vital role, your primary focus will be to serve as the Subject Matter Expert (SME) for the implementation of assay controls and reference standards. You will be instrumental in writing protocols and reports defining limits for these components across various chemistry methods, a crucial aspect of ensuring quality and compliance. Prior experience or knowledge in this area will be highly advantageous.
Other responsibilities include:
- Being the SME on QC Chemistry assays, involving testing, troubleshooting, and improvement efforts while ensuring alignment with cGMP standards.
- Supporting laboratory activities when unexpected analytical method trends arise.
- Approving QC test results for commercial products daily.
- Managing deviations, invalid assays, laboratory exceptions, CAPAs, and Change Controls.
- Collaborating closely with our colleagues in Analytical Development team to transfer methods into the department.
- Integrating new instruments in partnership with the QC Instrument support team.
- Authoring technical documents such as protocols and change control requests for successful project execution.
- Ensuring compliance with cGMP and participating in audits and inspections.
Qualifications and Education
The ideal candidate will have at least a Master’s degree in Biochemistry, Biology, Biotechnology, Pharmaceutical Sciences, or a related field. A PhD and/or experience in the pharmaceutical industry is highly preferred. You should possess strong knowledge of GMP and quality systems and have experience with various chemistry methods, including compendial testing and techniques such as HPLC, CE-SDS, and cIEF. Experience in method validation, qualification, and troubleshooting related to Drug Substance (DS) and Drug Product (DP) is advantageous.
We are looking for a person who has the right can-do-attitude and energy and understands the requirements in a cGMP QC laboratory. Someone who can handle a busy environment with many changing priorities without losing your good mood and overview. Someone who possesses excellent collaboration skills and who will nurture our OneQC mind-set where we aim at helping cross-functionally. You are curious, self-driven, dedicated, and systematic and can plan your projects and deliverables in a structured way. Professional efficiency in English is required as English is our corporate language.
If you can see yourself in this role, then we can offer an exciting and challenging job in a company with a very exciting future with many new partners and products and great possibilities for personal development and responsibility. Just as important - you will join a great team of very competent and engaged employees full of humor.
Application
Has this sparked your interest? Interviews will be conducted on an ongoing basis, so early applications are encouraged. For further details, please contact Associate Director Johan Aahman +45 41949701 or Martin Mikkelsen +45 26807765.
Deadline for applications: June 30.
FUJIFILM Biotechnologies is a global leader in biologics contract development and manufacturing Organization (CDMO), partnering with innovative biotech and biopharma companies to transform healthcare. With locations in Denmark, the UK, and the USA, we support every stage of our customers’ product lifecycle, from breakthrough cures to life-saving vaccines.
Our success starts with our people — their passion drives progress, innovation, and impact. Join a diverse, inclusive workplace that values collaboration, fosters growth, and empowers future generations. Together, we’re enriching communities, protecting the environment, and reimagining healthcare’s potential.
Shape the future with us — your drive meets boundless opportunity here https://fujifilmdiosynth.com/
FUJIFILM Biotechnologies Denmark is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, 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.
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What We Do
For over 30 years, FUJIFILM Diosynth Biotechnology’s mission has been advancing tomorrow’s medicine. As a CDMO, we work in partnership with the most innovative biopharma and biotech companies across the world who are reimagining healthcare’s potential. We help to accelerate their progress, expand their capabilities, streamline their processes, and strengthen their innovation. So when our customers’ potential cures, vaccines, biologics, and accomplishments make strides – or even become new realities for patients – we know our work, our manufacturing expertise, and our partnership helped make it happen.
FDB isn’t simply a workplace. It’s a place of passion – a place of what we call Genki. A place where diverse perspectives and people come to life. Where opportunity for growth has no end. Where passion is followed, discovered, and nurtured. Where the energy is undeniable, enthusiasm is pervasive, and drive is infectious. All of our global locations burst with curiosity, inspiration, and extraordinary purpose.
So as we continue to grow our teams, our global locations, and our capabilities, Genki will always be our cultural tie. That’s why we’re always looking for passionate, mission-driven people who want to commit their life’s work to enabling better outcomes for patients and their families.
For a full listing of jobs that will propel, inspire, and fulfill you, please visit: fujifilmdiosynth.com/careers/
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