QC Scientist – LC-MS development specialist

Alphalyse, Inc.; Odense; On-site; DKK 447,761 - 597,015; Full time

Benefits offered by this job

Collaborative work environment

Professional development opportunities

Team-oriented culture

Job summary

Alphalyse, Inc. is seeking an Analytical Development Specialist in Odense, Denmark to lead method development and validation for biopharmaceuticals using cutting-edge LC-MS technology.

Your role will involve collaborating across teams, ensuring compliance with GMP, and managing projects effectively. The ideal candidate holds a PhD in a relevant field with proven experience in mass spectrometry and strong communication skills.

The position offers a supportive environment focused on professional growth and impactful projects.

Qualifications

• Proven experience with development of mass spectrometry-based analytical methods.
• Hands-on experience working in a regulated environment.
• Experience with deviations, laboratory investigations, and change control.

Responsibilities

• Develop and validate LC-MS methods in compliance with GMP.
• Optimize analytical workflows and method performance.
• Prepare and review GMP documentation.

Skills

Mass spectrometry development

Analytical method validation

Project management

Communication skills

Education

PhD in Chemistry, Pharmacy or related field

Job description

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.

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.

What we offer

• 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 [e-mail]. 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 [phone].