Project Manager, BioAnalytics
Alvotech · Stockholm
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 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
Job 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 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.
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.