Laboratory Manager - 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 aManagerto setup and lead the laboratory equipment qualification and software validation group at theBioAnalytics Laboratory in Stockholm (Sweden). This role offers the opportunity to set up a new bioanalytical lab dedicated to the analysis of PK and immunogenicity samples originating from Alvotech's sponsored clinical trials.

We seek an experienced laboratory manager with a deep understanding of equipment qualification and software validation. Your expertise will be crucial in running the bioanalytical laboratory in compliance with global standards.

Scope and responsibility:

• Setup and management of processes for equipment qualification, equipment maintenance and software validation

• Implementation and coordination of sample management processes using LIMS (inhouse samples and samples received from clinical studies)

• Management of a laboratory temperature monitoring system

• Responsible person for the 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 5 years of experience in position related tasks

• Experience with equipment qualification and maintenance typical for bioanalytical labs, e.g. for spectrophotometer, ELISA reader (Electrochemiluminescence reader), plate washer, shaker, pH meter, balance, centrifuge, (deep) freezer, pipettes, temperature monitoring system

• Experience with software validation of relevant equipment software and LIMS to meet 21CFR part 11 requirements

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

• Good Technical knowledge and strong organization skills

• Experience with large molecules and biosimilars is of advantage

• 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.