Project Manager, BioAnalytics

Alvotech; Stockholms kommun; On-site; SEK 900,000 - 1,200,000; Full time

Benefits offered by this job

Wellness benefits

On-site changing rooms

Snacks, fruit and great coffee

Regular social events

Job summary

Alvotech seeks a Project Manager / Principal Investigator to lead bioanalytical studies at our Stockholm laboratory, driving high-quality support for clinical programs through method development, validation and analysis. The role requires close collaboration with lab teams to ensure scientific rigor and regulatory compliance.

The PM/PI will manage study timelines and resources, present data to stakeholders, and author plans and reports for validations and analyses, delivering timely, accurate

Qualifications

• Master’s or PhD preferred.
• 5+ years bioanalytical experience in pharma/biotech/CRO.
• Experience in method development/validation and PK/immunogenicity sample analysis.

Responsibilities

• Serve as scientific lead for bioanalytical studies analyzing PK and immunogenicity samples from planning to reporting.
• Lead method development, validation, and sample analysis per GCLP and SOPs.
• Manage project timelines, resources, risks and deliverables.
• Write, review and approve plans/reports for validations and analyses.
• Collaborate with lab teams, QA, operations and cross-functional partners to ensure data integrity and regulatory compliance.

Skills

Bioanalytical

Project management

Regulatory understanding

Communication

GCLP

ALCOA+ data integrity

PK/ADA analysis

English fluency

Education

Master’s or PhD in Biochemistry/Biology/Pharmaceutical Sciences

Tools

MSD ECL Technology

Job description

About the role:Alvotech is looking to hire a Project Manager / Principal Investigator to lead bioanalytical studies at Alvotech’s bioanalytical laboratory in Stockholm (Sweden) driving high quality analytical support for our clinical programs. This on-site role requires a regular presence at the Stockholm laboratory to enable close collaboration with laboratory teams and support day-to-day study activities.The Project Manager / Principal Investigator (PM/PI) is responsible for the scientific, operational, and regulatory oversight of bioanalytical studies supporting clinical programs. This role serves as the primary study lead, ensuring that all bioanalytical activities — including method development, method validation, clinical sample analysis and reporting — are conducted with scientific rigor, excellent communication, and full regulatory compliance. The PM/PI works closely with internal teams and external partners to deliver high-quality results on time and within scope.Key Responsibilities:Serve as scientific lead for bioanalytical studies to analyze clinical PK samples (quantitation of drug in serum) and immunogenicity samples (determination of anti-drug antibodies in serum (ADA/NAB)), from planning to reportingLead method development, method validation and sample analysis in compliance with GCLP requirements and SOPs (experimental planning and results evaluation)Manage project timelines, resources, risks, and deliverablesAct as primary contact for internal stakeholders; present data and study updatesWrite, review and approve plans/reports for validations/sample analysis studiesCollaborate with lab teams, QA (CMQ), operations, and cross functional partnersEnsure high standards of data integrity (ALCOA+), quality, and documentationJob Requirements:Degree in Biochemistry, Biology, Pharmaceutical Sciences, or related field (Master’s or PhD preferred)5+ years of bioanalytical experience in pharma, biotech, or ideally in CRO settingsProven experience in planning and executing method development/validation and bioanalytical studies (PK and immunogenicity sample analysis)Expertise with ligand binding assay platforms, e.g. MSD ECL TechnologyStrong knowledge of GLP/GCP and bioanalytical regulatory expectationsExposure to biosimilars or large moleculesStrong analytical mindset and excellent communication, organizational, and problem-solving skillsFluency in English, both written and spokenEntrepreneurial mindset with a passion for innovation and continuous improvement.Leadership experience is considered an advantage.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.