Leads bioanalytical studies supporting clinical programs, including PK and immunogenicity sample analysis, method development, validation, reporting, and regulatory compliance. Manages timelines, resources, risks, documentation, and stakeholder communication while ensuring data integrity and adherence to GCLP, GLP, GCP, SOPs, and ALCOA+ standards. The role is based on-site at the Stockholm laboratory and collaborates with laboratory, quality, operations, and external partners.
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.
- 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 reporting
- Lead 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 deliverables
- Act as primary contact for internal stakeholders; present data and study updates
- Write, review and approve plans/reports for validations/sample analysis studies
- Collaborate with lab teams, QA (CMQ), operations, and cross functional partners
- Ensure high standards of data integrity (ALCOA+), quality, and documentation
- 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 settings
- Proven 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 Technology
- Strong knowledge of GLP/GCP and bioanalytical regulatory expectations
- Exposure to biosimilars or large molecules
- Strong analytical mindset and excellent communication, organizational, and problem-solving skills
- Fluency in English, both written and spoken
- Entrepreneurial mindset with a passion for innovation and continuous improvement.
- Leadership experience is considered an advantage.
- 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.
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