Senior Technician or Scientist - 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 aSenior Technician or Scientistfor theBioAnalytics Laboratory in Stockholm (Sweden). This role offers the opportunity to join a new team dedicated to the analysis of PK, immunogenicity and biomarker samples originating from Alvotech's sponsored clinical trials.

We are seeking a flexible and motivated technician or scientist with experience in bioanalytical method development, method validation or clinical sample analysis working in a regulated laboratory. Your expertise will be crucial in running the bioanalytical laboratory in compliance with global standards.

Scope and responsibility:

• Performance (execution, documentation, troubleshooting) of bioanalytical method development and method validation (Drug concentration (PK), Immunogenicity, Biomarker)

• Analysis of samples (PK, Immunogenicity, Biomarker) from clinical studies in compliance with the study plan, SOPs and relevant international guidelines

• Support of report generation (development reports, transfer plans/reports, validation plans/reports, study sample analysis plans/reports)

• QC check of validation and sample analysis data

• Support of sample management (sample receipt, aliquotation, labeling, tracking etc.)

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

• Support of maintenance / qualification of relevant laboratory equipment

• General laboratory work to maintain laboratory operations such as autoclaving, preparing buffers/media, ordering, cleaning the workplace, etc.

Job requirements:

• Training as a Technician / Biological Technical Assistant (BTA)/ Bachelor with at least 2 years of experience in a relevant discipline (e.g. biology, immunology, biochemistry, biotechnology)

• Experience in the development or validation of bioanalytical assays or the analysis of clinical samples, e.g. for the quantitation of drug in serum (PK samples) or detection of anti-drug antibodies (ADA)

• Experience with immunological/bioanalytical methods, e.g. ELISA , Electrochemi-luminescence (ECL) by MSD

• Industry experience from work in a regulated environment (e.g. GCP, GLP) at a bioanalytical service provider is beneficial

• Knowledge and/or practical experience in cultivation of primary cells and/or cell lines under sterile conditions in a cell culture laboratory (Good Cell Culture Practice) is beneficial

• 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.