Senior Bioassay Scientist for QC Analytical Development

at  Fujifilm Diosynth Biotechnologies

Are you eager to join a fast-growing pharmaceutical company? Now you have a unique opportunity as we are looking for a Senior or principal bioassay scientist who shares our passion, drive, and energy – what we call Genki – to join the bioassay team in QC Analytical Development.
About the Position
In order to support the many new costumers and technology transfer programs, we are looking for a Drug Substance (DS)/Drug Product (DP) Bioassay Scientist to play a key role in the implementation of multiple new bioassay methods (e.g. ELISA assays, cell-based assays, qPCR, and dot plot).
When working in QC Analytical Development at FUJIFILM Diosynth Biotechnologies Denmark (FDBD) you will be involved in onboarding new customers and products to the site, build networks across QC and FDBD, support our site expansion projects, and assist in finding new and innovative ways of working smarter in a complex everyday life.
We work in a high paced and dynamic environment where we support the biologics Drug Substance production, as well as the global release of commercial products (DS/DP) for our clients.

Primary Responsibilities

• Author and review qualification, transfer, and validation protocols and reports as well as SOPs
• Support validation and implementation of new instruments in collaboration with the QC Instrument supporting team
• Data analysis and data evaluation
• Method development and troubleshooting
• Work in conjunction with the QC Bioassay & Virology testing team and contract laboratory organizations during method validation or transfer of validated methods
• Analytical method support to the QC testing team, including OOS investigational support as a SME (Subject Matter Expert)
• Change control Assessment of e.g., method changes, specification changes
• Ensure compliance with cGMP and participate in audits and inspections
• Ensure safety-first where you proactively keep an eye out for safety issues

Qualifications

• Master of Science in Biochemistry, Biology, Biotechnology, Pharmaceutical Sciences or similar and has preferably a PhD.
• You have solid understanding of GXP guidelines with minimum 5 years of experience from the biotech or pharmaceutical industry, e.g., from a QC bioassay laboratory or similar.
• You have a broad background in analytical methods, such as cell-based potency assays and ELISA assays, as well as knowledge of using JMP®/applying 4PL and 5PL analysis.
• Knowledge about Cell-based potency assays, ELISA assays, mycoplasma, and real time PCR will be considered an advantage.
• You preferably have experience with method transfer and validation, and are familiar with the ICH guidelines, the United States Pharmacopoeia, and the European Pharmacopoeia.

On a personal level, we are looking for a person with a can-do attitude and energy, and someone who understands the requirements in a GLP QC laboratory. You thrive in a busy environment with many changing priorities without losing the overview, and you can plan projects and deliverables in a structured way. You are curious, self-driven, dedicated, systematic, and possess excellent communications skills. Fluency in English is a requirement, as English is our corporate language. Finally, you welcome working from home.
In FUJIFILM we put people first and we always look for candidates with the right combination of personality and skills.
About QC Analytical Development Department
Our QC Analytical Development team in Hillerød currently consist of 47 dedicated employees – 7 project managers , 21 scientists, 12 analysts, 2 student helpers, 4 team leaders and a director. We are divided into a chemistry team, a raw material team, a bioassay team and a project lead team.
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 obligated 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.
Application
Has this sparked your interest? Then we urge you to send an updated 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 Associate Manager Line Vedel on phone: 91 35 71 10 or e-mail:
line.vedel@fujifilm.com
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.
About Us
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 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.
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.
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.

• Author and review qualification, transfer, and validation protocols and reports as well as SOPs
• Support validation and implementation of new instruments in collaboration with the QC Instrument supporting team
• Data analysis and data evaluation
• Method development and troubleshooting
• Work in conjunction with the QC Bioassay & Virology testing team and contract laboratory organizations during method validation or transfer of validated methods
• Analytical method support to the QC testing team, including OOS investigational support as a SME (Subject Matter Expert)
• Change control Assessment of e.g., method changes, specification changes
• Ensure compliance with cGMP and participate in audits and inspections
• Ensure safety-first where you proactively keep an eye out for safety issue