Virology and Bioassay Senior Scientist

Do you have extensive experience with viral safety of drug substance manufacturing combined with bioassay expertise and are you eager to join a fast-growing pharmaceutical company? Now you have a unique opportunity as we are looking for a virology and bioassay expert/principal scientist who shares our passion, drive, and energy – what we call Genki – to join QC Bioassay & Virology.

About FUJIFILM Diosynth Biotechnologies and our Quality Control 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 to “Advancing Tomorrow’s Medicines” and we like to invite you to be part of that journey.

Our Quality Control (QC) department at site Hillerød consists of approximately 250 employees divided into different support teams and three 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 also 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 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.

The culture at FUJIFILM Denmark (FDBD) is key if you ask our employees and besides a competitive salary and bonus package, we offer health insurance, massage and physiotherapy, health check, fitness center, possibility to work from home and most recently we invested in a mobile barista coffee van. FDBD also has a canteen arrangement incl. Friday brunch and monthly afternoon cake, just as we have a “bell ringing” tradition when reaching important milestones.

About the team
The QC Bioassay & Virology team currently consists of > 30 dedicated employees (analysts, scientists and a management group). The team supports the on-site biologic Drug Substance (DS) manufacturing by ensuring viral safety on products with in vitro Adventitious Virus testing, qPCR MMV testing and qPCR testing for impurity of in-process samples (IPT) as well as the global release of commercial products (DS/DP) for our customers with various potency and ID testing (e.g. cell-based assays, ADCC assays, ELISA based assays and dot blot). Method transfers, method validation and product specific qualification as well as generation of cell banks are becoming a key deliverable for the team with the many new customer products transferred to our manufacturing facility. And not least we perform qualification of controls and reference standards, handle deviations, CAPAs, invalid assays, OOS and Change Controls and much more. All this is part of our daily activities in respect of getting the commercial products out to the patients.

About the position
When working at FUJIFILM Diosynth Biotechnologies Denmark you will, besides from the tasks listed below, onboard new customers and products to the site, build a network across QC and FDBD and our global counterparts, support our site expansion project, and assist in finding new and innovative ways of working smarter in a complex everyday life.

Your primary tasks will be but not limited to:

• You will be scientific responsible (SME) on assays performed in QC Bioassay & Virology. This includes support to testing, improvements, troubleshooting and investigations in compliance with cGMP
• Laboratory support and support to scientist peers if unexpected analytical method trends are observed
• Support to the Drug Substance (DS) manufacturing with virology assessment as virology expert for deviation investigation
• Author technical protocols and reports e.g., for release of working cell banks for DS manufacturing or studies requested by customers
• Responsible for product specific qualification in relation to virology testing when transferring new products to our manufacturing facility
• Daily QC manager approval of test results for commercial product.
• Handling deviations, Invalid assays, Laboratory exceptions, CAPAs and Change Controls
• Ensure compliance with cGMP and participate in audits and inspections
• Be the QC SME/project lead in close collaboration with our Analytical Development department when transferring new methods for testing in QC laboratories as well as testing at CLOs
• Support to KojoX - global alignment across multiple sites, with specific focus on global alignment of QC processes
• Support to global counterparts
• Drive continuous improvements of practice in collaboration with management

Professional and Personal Qualifications
The ideal candidate holds a master’s degree in a relevant area and has preferably a PhD combined with experience from the pharmaceutical industry. You are experienced working under cGMP and preferably experienced with cell-based assays, cell culture maintenance, qPCR and virology testing. Large scale manufacturing knowledge is an advantage as well as knowledge of regulatory requirement and ICH guidelines in relation to viral safety.

We are looking for a person who has the right attitude and energy and understands the requirements in a cGMP QC laboratory. Someone who can handle a busy environment with many changing priorities without losing your good mood and overview and still paying attention to details. Someone who possesses excellent collaboration skills and who will nurture our OneQC mind-set where we aim at helping cross-functionally. You are curious, self-driven, dedicated, thorough and systematic and can plan your projects and deliverables in a structured way. Fluency in English is required as English is our corporate language.

At FDBD we put people first and we always look for candidates with the right combination of personality and skills. FUJIFILM Diosynth Biotechnologies will, as any other modern company, ask our employees for agility and flexibility from time to time but we always make sure to have a controlled work-life balance. We are many different nationalities and personalities at FDBD and for us to succeed we all need to focus on communication, take responsibility, organize, and execute on various tasks, solve problems, and display great interpersonal skills.

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 position as soon as we have found the right candidate.

In case you have any questions, please do not hesitate to contact Associated Manager Rasmus Biensø +45 31605961

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.

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