Development Scientist, Quality Control, Analytical Development Department

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 Development Scientist to join the Quality Control (QC), Analytical Development Department to play a key role in the development and implementation of new analytical methods, new analytical equipment, and scouting of new technologies to support our technology transfer programs.

The primary focus of the Department is to ensure timely implementation of analytical methods for analysis of process samples, reference samples, standards, and raw materials. You will collaborate broadly across QC. You will also ensure that we have methods in place to test for various metabolites and large molecules. In this position you will need to have the overview in a busy and changing work setting. A strong skill set in analytical methods and great communication is essential. Furthermore, you should have a flair for various software programs and laboratory robotics.

Primary responsibilities:

• Development and optimize analytical laboratory methods and protocols.
• Apply robotic methods and technologies to improve laboratory throughput.
• Scouting of new technologies and trends.
• Automation and streamlining of various analytical chemistry/biochemistry methods.
• Data treatment, technical report drafting and preparation.
• Work in conjunction with QC Analytical Development, QC Testing Teams and contract laboratory organizations during proof of concept of new methods and new technologies.
• Analytical method support to QC.
• Ad hoc QC projects within new technologies and equipment.
• Ensure safety-first where you proactively keep an eye out for safety issues.
  

Qualifications
On a personal level you are self-driven, dedicated, and 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 are welcome working-from-home.

Professional Qualifications:

• MSc or PhD within Pharmaceutical Sciences, Chemical Engineering, Chemistry, Biochemistry, Protein Chemistry, or Biology.
• Solid understanding of GMP/GLP guidelines with minimum 3 years of experience from the biotech or pharmaceutical industry, e.g. from a Research laboratory or QC laboratory.
• Broad background in analytical methods, such LC-MS/MS, GC-MS, HPLC and FT-IR as well as the capability of being able to absorb and utilize new knowledge quickly.
• Knowledge of data management, data analysis, and statistical treatment of data with programs such as Alteryx, JMP or similar software.
• Knowledge of laboratory automation and high throughput screening approaches including robotic programming and scripts.
• Knowledge of data integrity management and GAMP5 guidelines.
• Experience in the Unites 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.
• Have a safety-first mindset where you proactively keep an eye out for safety issues.
• Excellent English 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 on a fast-growing commercial pharma site with lots of development opportunities. We offer you dedicated colleagues, attractive salary package, work-life-balance and a brand-new fitness centre.

Application
Has this sparked your interest? Then we encourage 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 do not hesitate to reach out to Mette Ottosen, Director, Quality Control, Analytical Development Department, on [email protected]

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