Bioanalytiker

Temp-Team Danmark; Halsnæs Kommune; On-site; DKK 420,000 - 560,000; Full time

Job summary

Unilabs Pharma Solutions is seeking a Biomedical Laboratory Scientist/Bioanalyst to join a highly skilled bioanalytical team in a commercial laboratory servicing the pharmaceutical industry. The role focuses on executing bioanalytical testing, method development, validation, and ensuring compliance with GxP standards in a regulated setting.

You will generate high-quality analytical data, maintain meticulous documentation, and support validation activities, CAPAs, and audits.

Qualifications

• Degree as Biomedical Laboratory Scientist or equivalent.
• 2–5 years of experience in pharma/biotech/CRO in a regulated laboratory.
• Experience performing bioanalytical testing in a GxP-regulated environment.
• Hands-on ELISA assay experience.
• Fluent in Danish and English, both written and spoken.

Responsibilities

• Perform routine and non-routine bioanalytical testing per approved methods and SOPs.
• Execute ELISA-based assays with high accuracy and consistency.
• Review data and documentation for completeness, accuracy and compliance.
• Maintain, calibrate, troubleshoot and verify lab equipment to support efficient workflows.
• Support method development, optimization, validation, transfer and continual improvement of analytical methods and lab processes.
• Contribute to deviation investigations, change controls, CAPAs and audit readiness.

Skills

ELISA assays

Bioanalytical testing

Data integrity

Education

Biomedical Laboratory Scientist degree

Job description

This role will particularly suit candidates who enjoy spending the majority of their time conducting laboratory analyses and generating high-quality data, while also contributing to validation, compliance, documentation, and continuous improvement activities.

Do you thrive in a laboratory environment where high-quality analytical work is at the center of your daily responsibilities?

On behalf of Unilabs Pharma Solutions, we are seeking an experienced Biomedical Laboratory Scientist/ Bioanalyst to join a highly skilled bioanalytical team in a commercial laboratory providing solutions for the pharmaceutical industry. This role is ideal for a laboratory professional who enjoys performing analytical testing in a regulated pharmaceutical environment while contributing to method improvements, validation activities, and the maintenance of quality standards.

About The Role

The primary focus of this position is the execution of bioanalytical testing supporting pharmaceutical and biotechnology clients throughout drug development programs. You will be responsible for generating high-quality analytical data while ensuring full compliance with applicable regulatory requirements and quality systems.

You will join a collaborative laboratory team where analytical excellence, scientific rigor, and meticulous documentation are essential to success.

Analytical Testing (Primary Focus)

• Perform routine and non-routine bioanalytical testing according to approved methods, SOPs, and study protocols.
• Execute ELISA-based assays and other bioanalytical methods with a high degree of accuracy and consistency.
• Ensure timely delivery of analytical results while maintaining the highest quality standards.
• Review analytical data and documentation for completeness, accuracy, and compliance.
• Perform sample receipt, registration, processing, and analysis activities.

Key Responsibilities

• Maintain, calibrate, troubleshoot, and verify the performance of laboratory equipment, while supporting efficient laboratory workflows and ensuring laboratories remain inspection-ready.
• Participate in method development, optimization, validation, transfer, and continuous improvement of analytical methods and laboratory processes.
• Contribute to the qualification, implementation, and ongoing operation of laboratory equipment, technologies, assays, and designated operational areas.
• Perform all activities in compliance with GxP principles, including GCP, GCLP, GMP, ISO 15189, and pharmaceutical industry standards.
• Maintain accurate, complete, and traceable laboratory documentation, including support for SOP development and revision.
• Support deviation investigations, change controls, CAPAs, audit readiness activities, and participate in regulatory inspections and client audits as required.
• Support the training and qualification of laboratory colleagues and contribute to knowledge sharing across the team.

Who We Are Looking For

We are seeking a hands-on laboratory professional with a strong analytical mindset and experience working within a regulated pharmaceutical or biotech environment.

Qualifications

• Degree as a Biomedical Laboratory Scientist, Laboratory Technologist, Research Laboratory Technician, or equivalent scientific qualification.
• Minimum 2-5 years of experience in the pharmaceutical, biotechnology, CRO, or regulated laboratory industry.
• Practical experience performing bioanalytical testing in a GxP-regulated environment.
• Hands-on experience with ELISA assays is required.
• Strong understanding of laboratory documentation practices, data integrity, and compliance requirements.
• Experience following and working according to SOPs, validation protocols, and quality management systems.
• Fluent in Danish and English, both written and spoken.

To succeed in this role, you are

• Detail-oriented and quality-focused.
• Comfortable performing repetitive analytical work while maintaining accuracy and consistency.
• Structured and disciplined in your documentation practices.
• Proactive and able to work independently within established procedures.
• A collaborative team player who enjoys working in an international laboratory environment.

What Unilabs Offers

An exciting opportunity to work on pharmaceutical development projects with direct impact on patient care.

A modern laboratory environment in central Copenhagen.

Strong focus on scientific development and professional growth.

A collaborative team culture with experienced colleagues and a high level of technical expertise.

The opportunity to work with advanced bioanalytical methods in a regulated setting.

This role will particularly suit candidates who enjoy spending the majority of their time conducting laboratory analyses and generating high-quality data, while also contributing to validation, compliance, documentation, and continuous improvement activities.