Associate Director, Immunoassay Critical Reagents and Reference Materials

in Biochemistry, Immunology, Analytical Chemistry, Biological Sciences, or a related discipline with a minimum of 7 years of relevant biopharmaceutical industry experience; or M.S.

Significant hands-on experience with antibody reagent generation, screening, characterization, qualification, conjugation, labeling, lot bridging, stability assessment, and lifecycle management.

Demonstrated experience managing immunoassay critical reagents, reference standards, assay controls, calibrators, and customized assay materials used in ligand-binding assays or vaccine analytical methods.

Experience planning, executing, and interpreting critical reagent and reference material stability studies, including protocol design, storage condition selection, timepoint testing, acceptance criteria, trend analysis, expiry or retest dating recommendations, and stability reporting.

Strong understanding of antibody-antigen interactions, assay reagent quality attributes, specificity, affinity, cross-reactivity, epitope behavior, matrix effects, reagent stability, and lot-to-lot comparability.

Experience developing and executing qualification strategies for critical reagents and reference materials, including acceptance criteria, bridging approaches, stability monitoring, lifecycle planning, and replenishment planning.

The compensation package will be competitive and includes comprehensive benefits and an equity component.

$190,000 - $220,000

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Contribute to the establishment and growth of the Immunoassay Development Capability within Global Analytical Development organization, with primary responsibility for immunoassay critical reagents, reference materials, customized assay materials, stability programs, and associated lifecycle management systems.

Engage daily in laboratory operations, including reagent planning, reference material planning, sample and material readiness, laboratory study coordination, inventory review, data review, documentation, and hands-on technical support.

Lead the generation, characterization, qualification, stability planning, lifecycle management, and inventory control of antibody reagents used in immunoassays, including capture antibodies, detection antibodies, monoclonal antibodies, polyclonal antibodies, labeled antibodies, and other assay-specific binding reagents.

Support antibody reagent generation strategies, including antigen design, immunization strategy, hybridoma or recombinant antibody generation, screening, clone selection, purification, conjugation, labeling, characterization, and long-term supply planning.

Develop and execute antibody characterization plans, including specificity, affinity, cross-reactivity, epitope behavior, lot-to-lot comparability, assay performance attributes, stability, and suitability for intended immunoassay use.

Lead the generation, characterization, qualification, bridging, stability planning, lifecycle management, and inventory control of reference materials, including reference standards, assay controls, calibrators, system suitability controls, bridging controls, and other assay performance control materials.