Chromatography Expert/Senior Scientist for QC Chromatography
6 days ago
Do you have extensive experience with HPLC and Chromatographic analyses and are you eager to join a fast-growing pharmaceutical company? Now you have a unique opportunity as we are looking for a Chromatography expert/senior scientist who shares our passion, drive, and energy – what we call Genki – to join QC Chromatography.
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 230 employees divided into different support teams and four 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. 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.
About the team
The QC Chromatography team is currently consisting of 15 dedicated employees - 8 analysts, 3 scientists, a laboratory trainee, a student helper, a lab supporter and a manager, and we all enjoy working within the field of Liquid Chromatography (HPLCs and UPLCs). We support the biologic Drug Substance production as well as release testing of commercial products (DS/DP) for our clients together with stability testing, just as we take part method transfer, validation, and qualification for new customers. We also perform qualification of controls and reference standards, handle deviations, CAPAs, invalid assays, OOS/ OOT, change controls and much more. All this is part of our daily activities in respect of getting the commercial products out to patients.
About the position
When working at FUJIFILM Diosynth Biotechnologies Denmark you will, besides from the tasks listed below, onboard new customers and products to the site, build a network across QC, FDBD and our global sites in US and UK, support our site expansion project, and assist in finding new and innovative ways of working smarter in a complex everyday life.
Your primary tasks will be but not limited to:
- You will be scientifically responsible (SME) on Chromatographic assays performed in QC Chromatography. This includes support in relation to testing, improvements, troubleshooting and investigations in compliance with cGMP.
- Laboratory support if unexpected analytical method trends are observed.
- Author technical protocols and reports e.g., implementation of new control material for FDBD owned methods.
- Responsible for product specific qualification in relation to testing when transferring new products to our manufacturing facility.
- Daily QC manager approval of test results for commercial product.
- Handling deviations, Invalid assays, Laboratory exceptions, CAPAs and Change Controls.
- Ensure compliance with cGMP and be key SME during audits and inspections.
- Be the QC SME/project lead in close collaboration with our Analytical Development department when transferring new methods for testing in QC laboratories.
- Drive continuous improvements projects in collaboration with management.
Professional and Personal Qualifications
The ideal candidate holds a master’s degree in Biochemistry, Biology, Biotechnology, Pharmaceutical Sciences or similar and has preferably a PhD combined with experience from the pharmaceutical industry. You are experienced working under cGMP and preferably experienced with HPLCs/UPLCs and chromatography analyses. Large scale manufacturing knowledge is an advantage as well as knowledge of regulatory requirements and ICH guidelines. We are looking for a person who has the right attitude and dedication 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 and still paying attention to details. 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, thorough and systematic and can plan your projects and deliverables in a structured way. Fluency in English is required as English is our corporate language.
Application
Has this sparked your interest? Then we urge you to send an updated CV and cover letter as soon as possible. We will continuously invite relevant candidates for job interviews and will close the position as soon as we have found the right candidate.
In case you have any questions, please do not hesitate to contact Manager Anders Lorentzen at (or at +45 25662929).
Location: FDBD Hillerod
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Hillerød, Hillerød Kommune, Denmark FUJIFILM Diosynth Biotechnologies Full timeAbout FUJIFILM Diosynth BiotechnologiesWe are a world-leading Contract Development Manufacturing Organization (CDMO) serving customers in the pharmaceutical industry – from pre-clinical investigations to commercial GMP production. Our mission is to "Advance Tomorrow's Medicines" and we invite you to be part of that journey.Our Quality Control DepartmentOur...
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