QC Chemist

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 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 want to make a difference for QC, our site, our customers, and patients all over the globe.

About the QC Chemistry Department

The QC Chemistry department currently consists of over 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). Method transfers and method validation and qualification are becoming key deliverables for the department with the many new customers due to the site expansion of DS manufacturing together with the establishment of a Fill & Finish facility for drug product (DP). 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 include:

• You will be scientifically 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 products.
• 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’s Degree in Biochemistry, Biology, Biotechnology, Pharmaceutical Sciences or similar and 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. You should possess excellent collaboration skills and nurture our OneQC mindset where we aim at helping cross-functionally. 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.

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 at +45 41949701.