Senior/Principal QC Scientist — HPLC (Biologics, Antibodies)

We’re reposting this role after an initial round where we didn’t find the right match. We’re now open to hiring at Senior or Principal level, depending on experience. This is a hands-on, on-site role in our QC lab in Hillerød focused on HPLC method lifecycle, troubleshooting, tech transfers, and supporting junior colleagues - so biologics can be released from our production to patients in need.

What you’ll deliver (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

About the team and context

• You’ll join a group of nine scientists within QC Chemistry. Two analyst teams perform day-to-day lab testing; you act as an HPLC resource that bridges method ownership and execution.

• As a CDMO, we work with multiple customers and methods. The role translates customer requirements into phase-appropriate, compliant solutions aligned with our QMS and expectations from authorities (national and international).

Responsibilities

• Act as HPLC resource (Waters + Empower) for antibody analytics: SEC, Titer/ PepMap , and related methods

• Support daily release testing with data review and clean handovers

• Participate in tech transfers, method lifecycle activities, and control strategy implementation

• Write and review 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 QC release operations, including LIMS-related workflows and documentation

Must-haves

• Solid, hands-on GMP experience from QC/analytical labs in pharma/biologics (required)

• Deep HPLC expertise, preferably with Waters systems and Empower software

• E xperience with antibody methods (e.g., SEC, Titer/ PepMap )

• Experience with LIMS (e.g., LabWare )

• Ability to coach and support junior staff

Leveling guidance (Senior vs. Principal)

• Senior Scientist: Typically 5–9 years of relevant GMP QC/analytical experience; strong HPLC user, capable investigator, solid stakeholder collaboration

• Principal Scientist: Typically 10+ years; method lifecycle owner, complex troubleshooting lead, audit/inspection SME, coaches others and shapes control strategies

Nice-to-haves

• PhD in a relevant field (chemistry/biochemistry/pharmaceutical sciences or similar)

• 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

Benefits and working conditions

• 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

Submit:

• CV (max 3 pages)

• Short application (max 1 page) answering the two questions below

Application questions

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 CDMO: Share a situation where the path wasn’t black and white. How did you balance a customer’s or business 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.

Contact and timing

• Questions : Martin Mikkelsen at [email protected]

• Note: It’s vacation season—email replies may be delayed, and this posting will remain open longer than usual.

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.