QC Chemist

QC chemistry – your new team!
Are you a skilled scientist eager to join a fast-growing CDMO? We are looking for a scientist who shares our passion, drive, and energy – what we call Genki – to join QC Chemistry.

About FUJIFILM Diosynth Biotechnologies and our Quality Control Department
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 that journey.

Our Quality Control (QC) department at site Hillerød consists of approximately 240 employees divided into different support teams and three 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 currently consists of >30 dedicated employees (analysts, scientists, student helpers, and a leadership team). The department consists of 3 teams and supports the global release of commercial products (DS/DP) for our customers with various purity/impurity/pharmacopeia Chemistry methods (e.g. CESDS, ICE, SDS-page, HPLC/UPLC, appearance, pH, osmolality, SoloVPE/UV) as well as the support to the biologic Drug Substance (DS) manufacturing by ensuring TOC changeover and 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 of DS manufacturing together with establishment of a Fill & Finish facility for drug product (DP). And not least we perform qualification of controls and reference standards, handle deviations, CAPAs, invalid assays, OOS and Change Controls and much more. All this is part of our daily activities in respect of getting the commercial products out to the patients.

About the position
Your primary tasks will, amongst other, be:

• You will be scientific responsible (SME) on assays performed in QC Chemistry regarding testing, improvements, troubleshooting and investigations in compliance with cGMP.
• Laboratory support if unexpected analytical method trends are observed.
• Daily QC manager approval of test results for commercial product.
• Handling deviations, Invalid assays, Laboratory exceptions, CAPAs and Change Controls
• Be the QC SME/project lead in close collaboration with our Analytical Development department when transferring new methods for testing in QC laboratories.
• Implementation of new instruments in close collaboration with the QC Instrument supporting team
• Author technical protocols and reports as well as change control requests for ensuring successful execution of qualification and analytical improvement projects.
• Ensure compliance with cGMP and participate in audits and inspections.

Qualifications and Education
The ideal candidate holds a Master Degree in Biochemistry, Biology, Biotechnology, Pharmaceutical Sciences or similar and has preferably a PhD and/or experience from the pharmaceutical industry. You have knowledge of GMP and quality systems and preferably experience with various chemistry methods – both compendial and HPLC/CE-SDS/cIEF testing. Experience of method validation, qualification and troubleshooting related to DS and DP is an advantage.

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. Fluency 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? Then please upload your CV and cover letter as soon as possible and latest by January 15th 2025. For further details, please contact Associate Director Johan Aahman +45 41949701.

Working at FUJIFILM Diosynth Biotechnologies
FUJIFILM Diosynth Biotechnologies is a world leading cGMP Contract Development and Manufacturing Organisation (CDMO) with over 25 years of experience. As a world leading CDMO we combine technical leadership in cell culture, microbial fermentation and gene therapies with state of the art GMP manufacturing, from our network of four global locations in the USA, UK and DK. We currently employ over 2,000 dedicated staff who have a reputation for excellent customer service, flexibility and responsiveness.

As part of FUJIFILM Diosynth Biotechnologies you will be an active contributor in the advancement of tomorrow’s medicine. We take pride in enriching our communities, caring for our environment and cultivating a world of opportunity for future generations. We invest in you and what you care about, getting the right work-life balance for your health, your family and your professional growth.

FUJIFILM Diosynth Biotechnologies offers a healthy work environment that promotes individual responsibility, allowing you to grow and progress. We support our employees with programs that motivate and educate, promoting a healthy work-life balance that ultimately increases personal well-being and employee satisfaction.

Location: FDBD Hillerod