Scientist for QC Raw Materials Analytical Management Team

We are looking for a scientist that understands the quality setup of a QC laboratory in a GMP environment. A person that can handle a busy environment where priorities will shift without losing the good spirit and overview. You are a team player and understand the need for working close as a team, since we help each other to reach our ambitious goals. You can plan your day in a structural way and enjoy working in a team where there is room for a scientific discussion with a smile and a positive atmosphere.

About FUJIFILM Diosynth Biotechnologies and the QC Raw Materials 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 “Advancing Tomorrow’s Medicines”, and we would like to invite you to be part of that journey. QC Raw Materials consists of approximately 40 employees and is a dynamic department responsible for the readiness of all raw materials (RM) for production, at the manufacturing site in Hillerød. The department consists of four teams handling sampling, testing, and tech. transfer of RM for our current drug substance manufacturing (DSM) and the new drug product manufacturing facility (DPM). The pillar in our 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. We strive to continuously improve our way of working, ensuring “best place to work” and creating a dynamic and inspiring environment with huge individual co-decision making with flat organizational structure. We are a social department that values a good relationship between the teams, but also with the rest of QC and our other stakeholders both internally and externally.

About the Team
The QC RM Analytical Management team is responsible for testing and delivering GMP-compliant results on our raw materials used for production. Testing is mainly done according to pharmacopeias (primarily Ph.Eur., USP and JP) for release to the production and includes FTIR, Optical Rotation, LOD, titration, pH, osmolality, conductivity, appearance, ID, limit test and refractive index.

The team is currently composed of 2 Scientists (3 with you), 3 CLO responsible and 1 Supervisor working closely together with our Laboratory Testing team to move the samples safely from receival state in our laboratory to release for production.

About the position
As scientist in the QC RM Analytical Management, you will be part of a group of scientists and CLO responsible managing the approval and troubleshooting of analytical results for all raw materials to be released for production.

Qualifications

• You have a Master or Ph.D. in the natural sciences field e.g., Pharmacy, Chemistry, Biochemistry, Biophysics or similar.
• Experience with analytical chemistry is a plus but a newly graduated candidate is also welcome.
• Experience working with analysis of raw materials is an advantage.
• Pharmacopeial knowledge related to Ph.Eur., USP, JP and JPE is a plus.
• A mindset for optimizing daily work with the patience to implement them in a GMP-setup.

Primary tasks

• Approval of analytical test results of raw material samples in LIMS.
• Troubleshooting of methods and instruments in the laboratory.
• Participate in handling of deviations, OOS results, changes and CAPAs.
• Focus on continuous improvements to all our processes and challenging the status quo both in a supporting function and as a lead on own improvement projects.
• Document authoring and updates.
• Support a safe and healthy work environment with good cooperation and OneQC spirit.

If this is you, we can offer an exciting and challenging position with great possibilities for personal development in a company in growth with many new customers and products in the pipeline. On top of that you will be part of an organization and team of competent and engaged coworkers.

Application
Has this sparked your interest? Then we urge you to send an updated CV and cover letter as soon as possible. Please apply online in the HR system, applications received in other ways will not be considered.

We will continuously invite relevant candidates for job interviews and will close the position as soon as we have found the right candidate.

If you need more information
Contact person for interested applicants only:

Mikkel Haubro Schiøth, Supervisor for QC Raw Materials Analytical Management, [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 processes to improve lives.

Our Manufacturing site in Hillerød, Denmark, brings together a complete range of expertise, capabilities and technologies to manufacture advanced biologics. 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.

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