Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business.
Requirements
- PhD degree in a relevant scientific discipline (or equivalent experience).
- Typically 7+ years of relevant industry experience in bioanalytical sciences (large molecules), including responsibility for bioanalytical activities for clinical programs and support of late-stage development.
- Strong expertise in ligand binding assay platforms; experience with LC-MS for large molecules is a plus.
- Extensive experience in development and validation of PK, PD, or immunogenicity assays for large molecules, with a strong knowledge of applicable global regulatory guidance.
- Demonstrated understanding of GCP/GCLP expectations for bioanalysis of human samples and the ability to ensure inspection readiness across internal and outsourced activities.
- Proven experience leading outsourced bioanalytical work, including 3rd party lab selection, contracting support, governance, and performance management.
- Strong stakeholder management skills; proven experience representing Bioanalytics in clinical development teams and engaging as an expert counterpart with external partners.
- Strong experience preparing and reviewing bioanalytical regulatory documentation and contributing to regulatory plans/submissions; comfortable serving as SME in meetings with regulatory authorities.
- Excellent scientific judgment and problem-solving skills; able to drive resolution of complex, cross-functional issues in a fast-paced environment.
- Strong emphasis on quality, compliance, and data integrity; experienced in ensuring BA-related processes run smoothly and maintaining inspection readiness (internal and outsourced).
- Demonstrated coaching mindset; supports the development of bioanalytical team members and helps sustain strong knowledge of key BA methods and applicable regulations.
Benefits
- A competitive salary package, accompanied by comprehensive benefits.
- Opportunity to be part of a cross-disciplinary team involved in the (pre-)clinical development of therapeutic antibodies.
- Exposure to all aspects of pre-clinical and clinical development, both within the company and through collaborations with external vendors, contract partners, and the broader scientific community.
