Virology and Bioassay Senior Scientist
4 days ago
Virology and Bioassay Senior Scientist
Virology and Bioassay Senior ScientistApply locations Hillerod time type Full time posted on Posted 30+ Days Ago job requisition id JR3904
Do you have extensive experience with viral safety of drug substance manufacturing combined with bioassay expertise and are you eager to join a fast-growing pharmaceutical company? Now you have a unique opportunity as we are looking for a virology and bioassay expert/principal scientist who shares our passion, drive, and energy – what we call Genki – to join QC Bioassay & Virology.
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 250 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 team
The QC Bioassay & Virology team currently consists of > 30 dedicated employees (analysts, scientists and a management group). The team supports the on-site biologic Drug Substance (DS) manufacturing by ensuring viral safety on products with in vitro Adventitious Virus testing, qPCR MMV testing and qPCR testing for impurity of in-process samples (IPT) as well as the global release of commercial products (DS/DP) for our customers with various potency and ID testing (e.g. cell-based assays, ADCC assays, ELISA based assays and dot blot). Method transfers, method validation and product specific qualification as well as generation of cell banks are becoming a key deliverable for the team with the many new customer products transferred to our manufacturing facility.
About the position
Your primary tasks will be but not limited to:
- You will be scientific responsible (SME) on assays performed in QC Bioassay & Virology. This includes support to testing, improvements, troubleshooting and investigations in compliance with cGMP.
- Laboratory support and support to scientist peers if unexpected analytical method trends are observed.
- Support to the Drug Substance (DS) manufacturing with virology assessment as virology expert for deviation investigation.
- Author technical protocols and reports for release of working cell banks for DS manufacturing or studies requested by customers.
- Responsible for product specific qualification in relation to virology 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 participate in 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.
- Support to global counterparts.
- Drive continuous improvements of practice in collaboration with management.
Professional and Personal Qualifications
The ideal candidate holds a master’s degree in a relevant area and has preferably a PhD combined with experience from the pharmaceutical industry. You are experienced working under cGMP and preferably experienced with cell-based assays, cell culture maintenance, qPCR and virology testing.
We are looking for a person who has the right 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 and still paying attention to details.
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 Associated Manager Rasmus Biensø +45 31605961.
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