QC Scientist – LC-MS development specialist
Role highlights
Full Time
Permanent
Senior
On-site
The QC Scientist – LC-MS Development Specialist role requires advanced expertise in developing and validating liquid chromatography-mass spectrometry (LC-MS) methods specifically for biopharmaceutical applications within GMP-regulated environments. Candidates must hold a PhD in Chemistry, Pharmaceutical Sciences, Biotechnology, or a related scientific discipline, demonstrating a high level of education and scientific rigor. Proven hands-on experience in mass spectrometry-based analytical method development and validation is essential, with a strong focus on regulatory compliance and quality standards. The role demands proficiency in preparing and reviewing GMP documentation, including protocols, reports, SOPs, risk assessments, and deviation investigations, as well as supporting audits and inspections. Project management skills are critical, encompassing defining project scopes, coordinating timelines, and ensuring on-time, high-quality deliverables. Effective communication and collaboration skills are necessary to lead cross-functional teams and train colleagues, fostering continuous improvement. Familiarity with laboratory investigations, change control, and data integrity principles is highly beneficial. Experience within a QC laboratory and in pharmaceutical or biotech settings enhances suitability. The position emphasizes accountability, quality focus, and the ability to proactively address challenges in a dynamic, team-oriented environment. Overall, this senior-level role combines deep technical knowledge of LC-MS analytical techniques with strong regulatory, documentation, and project leadership capabilities to support cutting-edge biopharmaceutical development and product release.
About the role
Role Summary
- Develop and validate LC-MS (mass spectrometry) methods for biopharmaceuticals under GMP
- Ensure robust analytical solutions to support product development and release
- Collaborate closely with QC, QA, lab teams, and other development functions
- Coordinate timelines and deliverables for high-quality, on-time execution
- Lead cross-functional efforts and proactively address project challenges
Responsibilities
- Develop and validate LC-MS methods in compliance with GMP and regulatory guidelines
- Optimize analytical workflows and monitor method performance
- Define validation project scope and timelines, ensuring steady progress
- Prepare and review GMP documentation (protocols, reports, method instructions, SOPs, risk assessments, deviation/investigation records)
- Support audits and inspections related to analytical methods and validation
- Train team members and contribute to continuous improvement
Requirements
- 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 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
Nice to Have
- Experience from a QC laboratory
- Experience with method validation
- Knowledge of data integrity principles
- Familiarity with cross-functional work in pharma or biotech organizations
Benefits
- Collaborative, respectful, and flexible work environment
- Strong team-oriented culture focused on professional development and personal fulfilment
- Role that values accountability, high quality, and close collaboration
- Opportunities to work on cutting-edge projects that contribute to improved biologics and Alphalyse's success
How to Apply
- Send your application as soon as possible, and no later than February 2, 2026, to [email protected]
- Applications are reviewed on an ongoing basis; interviews are held 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. The company specializes in protein analysis to help clients develop safe and effective biopharmaceuticals. Alphalyse is a world leader in quantifying Host Cell Protein using a unique mass spectrometry method. The technical experts at Alphalyse make analysis results accessible and build strong relationships with clients. The team of highly skilled employees is the company's most important asset, and the work environment is exciting, challenging, and fun.
Learn more at www.alphalyse.com
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