QC Scientist – LC-MS development specialist
Would you like to push the boundaries of biologics development and quality control using advanced LC-MS analytical methods? Alphalyse now seeks an Analytical Development Specialist to work on cutting-edge LC-MS method development and validation.
About the role
As an experienced Analytical Development Specialist with expertise in LC-MS you will develop and validate mass spectrometry (MS) based methods for biopharmaceuticals under GMP. You will ensure robust analytical solutions that drive product development and release.In this role, you will work closely with QC, QA, lab teams, and other development functions, coordinating timelines, and deliverables for high-quality, on-time execution. You will lead cross-functional efforts and proactively address challenges to keep projects on track.
Your responsibilities
Development and validation of LC-MS methods in compliance with GMP and regulatory guidelines.- Optimization of analytical workflows and method performance trending
- Defining validation project scope, timelines, and ensuring steady progress
- Preparing and reviewing GMP documentation (protocols, reports, method instructions, SOPs, risk assessments, and deviation/investigation records)
- Supporting audits and inspections related to analytical methods and validation
- Training team members and contributing to continuous improvement
Who you are
You will thrive in this role if you are a clear communicator, detail-driven, and passionate about quality. Your collaboration is based on trust and alignment of expectations. You love solving complex problems, thrive in structured workflows, and enjoy working across teams.Adaptable under pressure, you keep deadlines on track and stay ahead of regulatory and analytical trends.
Professional Qualifications
Required:
- PhD in a relevant scientific field (e.g. Chemistry, Pharmaceutical Sciences, Biotechnology, or similar)
- Proven experience with development of mass spectrometry-based analytical methods
- Hands-on experience working in a regulated environment
- Ability to manage large projects in a structured and quality-focused manner
- Experience with deviations, laboratory investigations, risk assessments, and change control
- Strong written and verbal communication skills in English
Preferred:
- Experience from a QC laboratory
- Experience with method validation
- Knowledge of data integrity principles
- Familiarity with cross-functional work in pharma or biotech organizations
- A collaborative, respectful, and flexible work environment where your expertise makes a real impact
- A strong team-oriented culture with focus on professional development and personal fulfilment
- A role that values accountability, high quality, and close collaboration
- Opportunities to work on cutting-edge projects that contribute directly to improved biologics and the continued success of Alphalyse
Are you interested in the position?
Please send your application as soon as possible or no later than February 2, 2026, to thyssen@alphalyse.com. We review applications on an ongoing basis and invite candidates for interviews continuously. Include a letter of motivation, CV, and relevant diplomas.
For more information, contact Head of QC Department, Stine Thyssen or Head of Characterization & Data-Driven Innovation, Katrine Pilely, at +45 63 10 65 07.
About Alphalyse
Alphalyse is a Danish contract research laboratory founded in 2002. We use our passion for protein analysis to help clients develop safe and effective biopharmaceuticals. An innovative approach has made us world leaders in quantifying Host Cell Protein using a unique mass spectrometry method.
Our technical experts make the analysis results accessible to understand and use, and they take pride in building strong and rewarding relationships with our clients. Our most important asset is our team of highly skilled employees, and we encourage a work environment that is exciting, challenging, and fun.
Learn more about Alphalyse at www.alphalyse.com