Biopharmaceutical Scientist for Drug Substance and Product Development
5 days ago
We are expanding our large-scale facility to accommodate 20 x 20,000L bioreactors for drug substance production. Our first Filling Facility in Denmark is under construction.
As a key member of our team, you will play a crucial role in implementing multiple chemistry methods to support technology transfer programs between our customers and FujiFilm. We work with a range of analytical techniques, including UV, SoloVPE, SDS-PAGE, icIEF, CE-SDS, SEC, CEX, IEC, RP, PS80, titer, PepMap, and other compendial methods such as sub-visible particles, pH, Appearance.
As part of our Analytical Development team, you will work closely with approximately 8 dedicated colleagues – chemists and laboratory technicians. The primary focus of the team is to ensure timely implementation of new analytical test methods for release testing. You will interact with various stakeholders – both internally from DS and DP production, QC testing teams, as well as external stakeholders such as contract laboratory organizations.
We support the biologics drug substance (DS) production as well as the global release of commercial products (DS/Drug Product) for our clients.
In this role, you will work closely with your colleagues in the team – chemists as well as laboratory technicians, so good communication and collaborative skills are essential. Your responsibilities will include authoring and reviewing qualification and transfer/validation protocols, reports, and SOPs, supporting the implementation and setup of new instruments, method troubleshooting, data analysis, and evaluation, working in conjunction with QC testing teams and contract laboratory organizations during method transfers of validated methods and compendial method verifications, analytical method support to QC testing teams, including OOS investigative support as a SME, change control assessment of e.g., method changes, specification changes, and ensuring safety-first by proactively identifying potential safety issues.
On a personal level, you are self-driven, dedicated, systematic, and able to plan projects and deliverables in a structured way. You are flexible and have a positive attitude, energy, and humor. You thrive in a fast-changing environment and are interested in developing yourself. You enjoy collaboration with colleagues but also work well independently. You welcome working-from-home.
Professional Qualifications:
- Master of Science within Pharmaceutical Sciences, Chemical Engineering, Chemistry, Biochemistry, Protein Chemistry, or Biology
- Solid understanding of GMP/GLP guidelines with minimum 5 years of experience from the biotech or pharmaceutical industry or university – e.g., from a QC chemistry laboratory or similar
- Broad background in analytical methods, such as icIEF, CE-SDS, and U/HPLC
- Experience in the United States Pharmacopoeia and the European Pharmacopoeia
- Knowledge of ICH guidelines is an advantage, but not a requirement
- Experience with method transfer and validation
- Excellent oral and written communication skills
About Our Department
Our QC department is divided into an Analytical Development team, different support teams, and five testing teams. In QC, we strive towards a OneQC team spirit, where we help and support each other across teams to reach our goals and support high-level 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 obliged 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.
What We Offer
The culture at FDBD is the most important aspect if you ask our employees, and the opportunity to participate in an exciting journey in a fast-growing commercial pharma site with lots of development opportunities. We offer dedicated colleagues, attractive salary package, work-life-balance, a brand-new fitness centre, and last but not least a lovely Barista Coffee wagon.
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