Enabling patients with autoimmune diseases to reimagine life. Backed by NEA and Norwest.
About the role
The Director of Analytical Development and Quality Control will lead the strategy, development, and execution of analytical methodologies to support biologics product development from early research through commercialization. As a key member of the Technical Operations team, the ideal candidate will have deep scientific expertise in cell-based assays, leadership experience, and a proven ability to work cross-functionally in a fast-paced biotech environment.
What they're looking for
- Bachelor’s degree in Chemistry, Biochemistry, Analytical Sciences, or a related field required, advanced degree preferred
- 10+ years of relevant experience in analytical development within the biopharmaceutical or biotechnology industry
- Strong background in biological cell-based assay method development
- Experience in small-molecule analytical is a plus
- Proven experience with method development, validation, and regulatory submissions
- Deep understanding of ICH, FDA, and EMA regulatory requirements
More about this role
Zenas is a clinical-stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients with autoimmune diseases. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Zenas is advancing two late-stage, potential franchise molecules, obexelimab and orelabrutinib. Obexelimab, Zenas’ lead product candidate, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. We believe that obexelimab’s unique mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. Orelabrutinib is a potentially best-in-class, highly selective CNS-penetrant, oral, small molecule Bruton’s Tyrosine Kinase...
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