Principal Scientist in Bioanalytics and

**Overview of Role**

The Principal Scientist will be part of the Clinical and Medical Affairs Department (CMA) reporting to the Director of Bioanalytics and Translational Medicine. In that role the Principal Scientist is responsible for the planning, coordination and evaluation of bioanalytical and translational medicine processes (method development, method validation, sample analysis) performed either at external bioanalytical vendors or inhouse within our translational medicine lab as part of non-clinical and clinical studies on behalf of Alvotech.

**Scope and responsibility**
- Oversight, coordination and evaluation of experiments for method development (assessment of drug concentration (PK), immunogenicity (ADA, NAB) and Biomarker), method transfer and method validation at external vendors or inhouse
- Oversight and coordination of sample analysis (bioanalytical samples, translational medicine samples) from preclinical and clinical studies at external vendors or inhouse
- Reconciliation of bioanalytical data within clinical studies including generation/review of DTA
- Generation/review/approval of validation/study plans, protocols and development/validation/study reports
- Support of project management activities within BTM group in respect to project timelines, budget, analytical capacity and material costs
- Support of vendor selection processes to select vendors for external activities
- Presentation of project updates in team meetings
- Support of other functions within CMA department related to bioanalytical and biomarker sample analysis from clinical studies (e.g. review of clinical study plans, review of laboratory manuals, supporting the planning of sample kit assembly)
- Support of QM/QA standards (creation or revision of SOPs, forms, deviations, amendments, CAPAs etc.)

**Job requirements**
- M.Sc./Diploma and at least 5 years industry experience in the Biopharmaceutical sector (PhD is beneficial)
- Practical and theoretical experience in method development (PK, ADA, NAB, cell-based assays, (pre)clinical assays, biomarker), method validation and performance of bioanalytical/biomarker studies for the analysis of nonclinical and clinical samples
- Good knowledge of international GxP related guidelines for method development, method validation and analysis of nonclinical and clinical samples, e.g. ICH, EMA, FDA, USP
- Experience in project management including proposal writing, customer support, budgeting and project coordination is beneficial
- Excellent written and verbal communication skills
- Good command of English, both written and verbal
- Proficient in use of a PC and common Microsoft Office packages

**About the Department/Company**

Alvotech is a biotech company, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products and services, enabled by a fully integrated approach and broad in-house capabilities.

The Bioanalytics and Translational Medicine group is part of the Clinical and Medical Affairs Department (CMA). The Bioanalytics subgroup is responsible for the planning and coordination of all bioanalytical tasks as part of (non)clinical studies performed by Alvotech at external bioanalytical vendors. The Translational Medicine subgroup is working on a broad spectrum of methods including biomarker determination, target engagement, proof of concept or patient safety, all in the light of bridging our product safely from laboratory analysis to the patient treatment.

The Bioanalytics and Translational Medicine group is an integral part of all clinical studies and interacts closely with other functions within the CMA (Clinical Development, Clinical Operations, Data Management, Statistics), within Alvotech (Regulatory Affairs, QA, Analytics) and with external vendors (bioanalytical and clinical CROs, Central labs).

**Why Alvotech**

At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We’re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.

True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let’s create a healthier world together, through affordable biologic medicines.