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Fujifilm Diosynth Biotechnologies
Chemistry Scientist for Technical Transfer Team
Hillerød
October 9, 2024
We are looking for a Chemistry Scientist with Drug Substance (DS) and Drug Product (DP) analytical experience to play a key role in the implementation of analytical method transfer of multiple chemistry methods to support technology transfer programs between our customers and Fuji Film. For the DS track we work with implementation of methods like UV, Solo VPE, SDS-PAGE, CE-SDS, ic IEF, U/HPLC-based methods, e.g. CEX, SEC, Glycan, PS80, Titer and Pep Map.
Primary Responsibilities
- Implement analytical methods related to DP and/or DS
- Author and review qualification and transfer/validation protocols, reports and SOPs
- Method troubleshooting, data analysis and data evaluation
- Work in conjunction with QC testing teams and contract laboratory organizations during method transfers of validated methods and compendial methods
- Analytical method support to QC testing team, including OOS investigational support as a SME
- Change control assessment of e.g., method changes, specification changes
- General knowledge of aseptic processes is considered an advantage
- 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 is an advantage
- Experience with DP analysis such as Appearance/p H/Color/Clarity/sub-visible particles testing/Break loose gliding force
- Experience with DS analytical methods, such as UV, Solo VPE, ic IEF, CE-SDS and U/HPLC
- Experience in the Unites States Pharmacopoeia and the European Pharmacopoeia
- Knowledge of ICH guidelines are an advantage, but not a requirement
- Experience with method transfer and validation
- Excellent oral and written communication skills
Has this sparked your interest? Then we urge you to upload your CV and cover letter as soon as possible. We will continuously invite relevant candidates for job interviews and will close the job advertisement as soon as we have found the right candidate.
FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark, Teesside, UK, RTP, North Carolina and College Station, Texas, USA. We use our skills, dedication, and ambition to enable impact for the world’s most innovative biotech and biopharma companies reimagining healthcare’s potential. We work across the entire lifecycle of our customers’ products – enabling success throughout. Every cure, vaccine, biologic, and advancement we contribute to starts with our people and our passion. We fuel one another’s passion, help accelerate progress, expand capabilities, strengthen innovation, and improve.
Our site in Hillerød, Denmark, brings together expertise, capabilities and technologies to manufacture advanced biologics. The large scale manufacturing facility has a capacity of 120,000 liters to reliably manufacture biologics for late phase and commercial use. We commenced 6 billion DKK projects to double our manufacturing capacity and to add fill finish to the site.
We offer the chance to be part of a global workplace where passion, drive and commitment are met with opportunities for professional and personal development. Deeply committed to diversity and inclusion, we ensure that everyone no matter their background or gender has an opportunity to develop. We take pride in enriching our communities, caring for our environment, and cultivating a world of opportunity for future generations.
As we continue to enhance and expand our capabilities, we are looking for people who share our passion, drive, and energy – what we call Genki – to join our team.
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