Scientist or Senior Technician, BioAnalytics

Alvotech; Stockholms kommun; On-site; SEK 600,000 - 840,000; Full time

Benefits offered by this job

Meaningful Work

Global growth opportunities

Collaborative environment

Career development

Cultural exchange

Job summary

Alvotech seeks a Scientist or Senior Technician for the BioAnalytics Laboratory in Stockholm, Sweden. You will contribute to PK, immunogenicity and biomarker analyses from clinical trials in a regulated setting, performing method development, validation and sample analysis with QA support.

The role requires a biology/biochemistry background with 2+ years in bioanalysis, ELISA/ECL proficiency, and English fluency.

Qualifications

• Training as a Technician / BTA or Bachelor with 2+ years in biology, immunology, biochemistry or biotechnology.
• Experience in bioanalytical assay development or validation and clinical sample analysis.
• Experience with immunological/bioanalytical methods (ELISA, ECL) in a regulated setting.

Responsibilities

• Perform bioanalytical method development and validation for PK, ADA, and biomarkers.
• Analyze clinical samples in compliance with study plans and SOPs.
• Support generation of development/validation reports and transfer plans.
• QC check validation and data, support sample management and QM/QA processes.
• Maintain/qualify lab equipment and perform general lab duties.

Skills

Bioanalytical method development

Method validation

Clinical sample analysis

ELISA

ECL MSD

PK analysis

ADA detection

GLP/GCP

Cell culture

Education

Bachelor's degree in biology or related field

BTA/Technician training

Tools

ELISA

MSD ECL

Cell culture

Job description

About the role:Alvotech is looking to hire a Scientist or Senior Technician for the BioAnalytics 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.Key Responsibilities:Performance (execution, documentation, troubleshooting) of bioanalytical method development and method validation (Quantitation of drug concentration (PK), Immunogenicity (ADA/NAB), Biomarker)Analysis of samples (PK, Immunogenicity, Biomarker) from clinical studies in compliance with the study plan, SOPs and relevant international guidelinesSupport of report generation (development reports, transfer plans/reports, validation plans/reports, study sample analysis plans/reports)QC check of validation and sample analysis dataSupport 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 equipmentGeneral 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 MSDIndustry experience from work in a regulated environment (e.g. GCP, GLP) at a bioanalytical service provider is beneficialKnowledge 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 beneficialFluency in English, both written and spokenWhat 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.