Bioanalytical PM/PI: Lead PK & Immunogenicity Studies

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

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