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Development Scientist, Quality Control, Analytical Development Department
1 week ago
We are expanding our large-scale facility to encompass 20 x 20,000L bioreactors for Drug Substance production. We are well in-progress on building our first Filling Facility in Denmark.
Therefore, we are looking for people with “Genki”, which is one of our four values, it’s Japanese for passion, energy, and fun. We believe in teamwork, a variety of tasks and giving responsibility to those closest to the work. We believe in people
About the Position
We are looking for a Sr. Chemistry Scientist in Drug Substance (DS) and Drug Product (DP) to play a key role in the implementation of multiple chemistry methods to support technology transfer programs between our customer and FujiFilm. We work with implementation of methods like 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 .
You will be part of a team with app. 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 many different 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 also work closely with your colleagues in the team – chemists as well as laboratory technicians, so good communication and collaborative skills are a necessity.
Primary Responsibilities
- Author and review qualification and transfer/validation protocols, reports and SOPs
- Support implementation and set up of new instruments
- 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 method verifications
- Analytical method support to QC testing team, including OOS investigational support as a SME
- Change control assessment of e.g., method changes, specification changes
- Ensure safety-first where you proactively keep an eye out for safety issues
Qualifications
On a personal level you are self-driven, dedicated, systematic and able to plan your projects and deliverables in a structured way. You are flexible and have a positive attitude, energy, and humour. 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 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
About the 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 not only to reach our goals but 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 wants 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 can we offer (#StrivingToBeTheBestPlaceToWork )
The culture at FDBD is the most important 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 you dedicated colleagues, attractive salary package, work-life-balance, a brand-new fitness centre, and last but not least a lovely Barista Coffee wagon.
Application
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.
In case you have any questions, please reach out to the teamleader in QC Chemistry - Analytical Development: Jonas Jensen on or call on +45 4194 9850.
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.
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.
We aim to foster a collaborative, innovative and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values. We pursue our fullest potential as individual contributors and team members. We strive to be the employer of choice and offer a competitive compensation and benefit package.
FUJIFILM Diosynth Biotechnologies Denmark (FDBD) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identify or any other protected class.
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
Location: FDBD Hillerod
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