Principal Scientist — QC Chemistry
FUJIFILM Biotechnologies
What You’ll Deliver In The First 12 Months
- Build a clear overview of our HPLC methods, their purpose, and customer impact
- Support complex troubleshooting, tech transfers, and deviations/CAPAs in a GMP setting
- Coach junior staff in practical GMP, data integrity, and clear scientific reasoning
- You’ll join a group of nine other scientists within QC Chemistry. Two additional analyst teams perform the day-to-day lab testing; you act as a senior HPLC resource that bridges method ownership and execution.
- As a CDMO, we work with multiple customers and methods. The role requires translating customer requirements into phase-appropriate, compliant solutions that meet expectations from authorities (national and international) and our QMS—while negotiating realistic timelines and changes.
- This is a replacement position.
- Act as senior HPLC resource (Waters + Empower) for antibody analytics: SEC, Titer/PepMap, and related methods
- Support junior staff with daily release testing, review data, and ensure clean handovers
- Participate in tech transfers, method lifecycle activities, and control strategy implementation
- Write and review complex deviations, CAPAs, risk assessments, and change controls
- Prepare for and participate in audits/inspections; respond pragmatically under pressure
- Implement and maintain standards, controls, and system suitability criteria
- Support overall QC release operations, including LIMS-related workflows and documentation
- 10+ years’ QC/analytical experience under GMP
- Deep HPLC expertise, preferably with Waters systems and Empower software
- Strong experience with antibody methods (e.g., SEC, Titer/PepMap)
- Experience with LIMS (e.g. LabWare)
- Proven track record coaching and developing junior scientists/technicians
- A PhD in a relevant field (chemistry/biochemistry/pharmaceutical sciences or similar) or similar experience.
- Experience with CE-SDS, icIEF, and general chemistry methods
- Method validation/qualification, robustness studies, and lifecycle management
- Prior exposure to inspections by authorities (national and international) and customer audits
- Competitive salary with bonus plan
- Employer pension contribution
- Comprehensive health insurance package
- Flexible work: primarily on-site; occasional WFH for documentation/review as needed
- Well-run on-site amenities: quality canteen, gym, café; free coffee stations
How to apply
- CV (max 3 pages)
- Short application (max 1 page) answering the two questions below
Mentoring: Describe a concrete example of how you coached junior staff (scientific and GMP). What changed in their performance or quality outcome as a result?
Navigating GMP ambiguity in a previous work: Share a situation where the path wasn’t black and white. How did you balance or business or a customer’s needs with compliance and science to reach a defendable decision?
AI-use disclosure: You may use AI tools to help draft your application. If you do, please, disclose which parts were assisted by AI and which tool(s) you used.
For questions please reach out to Martin Mikkelsen at [email protected] (write to schedule a call if needed)
We review applications on a rolling basis. Early applications are encouraged.
FUJIFILM Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark; Teesside, United Kingdom; RTP, North Carolina; Holly Springs, North Carolina; and College Station, Texas. 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.
The culture 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 and hybrid working. Our facility also has a canteen arrangement incl. Friday brunch and monthly afternoon cake, just as we have a “bell ringing” tradition when reaching important milestones.
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.