Laboratory Specialist Bioanalytics

Om jobbet

About the Department/Company

Alvotech is a fully integrated specialty biopharmaceutical company focused exclusively on development and manufacturing of high-quality biosimilar medicines.

Within Research and Development (R&D) function, the integrated Clinical and Medical Research (iCMR) department develops effective strategies aligned with biosimilar guidelines and health authority requirements to deliver successful clinical studies, and support post marketing-authorization related activities.

iCMR is launching an ambitious and exciting project aimed at modernizing and optimizing the departmental operating model. As part of this project, we are recruiting for the following position:

Overview of Job Role

Alvotech is looking to hire aLaboratory Specialist to perform laboratory equipment qualification and software validation at theBioAnalytics Laboratory in Stockholm (Sweden). This role offers the opportunity to play an important role in running a new bioanalytical lab dedicated to the analysis of PK and immunogenicity samples originating from Alvotech's sponsored clinical trials.

We are seeking a flexible and motivated laboratory specialist with good technical knowledge and experience in equipment qualification as well as software validation. Your expertise will be crucial in running the bioanalytical laboratory in compliance with global standards.

Scope and responsibility:

• Planning, execution and documentation of equipment qualification, equipment maintenance and software validation

• Performance of sample receipt, sample aliquotation, sample labeling and sample tracking processes using LIMS (inhouse samples and samples received from clinical studies)

• Maintenance of laboratory temperature monitoring system and documentation/evaluation of temperature readouts

• Support of archival processes (data and material archive)

• Support of sample logistics processes (shipment of samples from trial sites)

• Support of QA processes (deviations, CAPA, SOP generation/update, inspections/audits etc.)

• Ensuring GCLP compliance and high-quality standards for Alvotech's sponsored clinical trials

Job requirements:

• Training as a Master/Engineer in a related discipline (e.g. biology, biotechnology, biochemistry)

• Minimum of 2 years of experience in position related tasks

• Experience with equipment qualification and maintenance

• Experience with software validation

• Experience of work in a regulated environment (e.g. GCP, GLP) is of advantage

• Good technical knowledge

• Fluency in English, both written and spoken.

What we offer:

• Meaningful Work: Tackle inspiring challenges with passionate colleagues on projects that make a real difference in people's lives.
• Global Growth: Join a fast-growing, international company with a diverse and inclusive culture.
• Collaborative Environment: Work in a positive, flexible, and innovative setting that values teamwork and creativity.
• Career Development: Benefit from support for personal growth, internal mobility, and ongoing training opportunities.
• Cultural Exchange: Take advantage of exchange opportunities with our Reykjavik, Iceland lab for short or long-term stays.
• Well-being & Perks: Enjoy wellness benefits, on-site changing rooms, and a stocked office with snacks, fruit, and great coffee.
• Community & Celebration: Participate in regular social events and celebrate team milestones together.