Sr. Scientist, Critical Reagents

Role Summary

We are seeking a highly motivated Senior Scientist to lead the outsourcing and lifecycle management of critical reagents supporting programs from Research through Clinical development. This role will provide technical leadership and hands-on oversight for the generation, characterization, qualification, and supply of critical reagents used in nonclinical and clinical studies. The ideal candidate has direct experience developing critical reagents (labeled reference materials, polyclonal antibodies, anti-idiotype antibodies, peptide pools, etc.) and working with external partners to ensure quality, compliance, and continuity of supply. This individual will work cross-functionally to ensure reagent readiness aligned with developmental program timelines.

Responsibilities

• Lead external development and qualification of critical reagents to support bioanalytical assays from non-GLP through clinical
• Provide scientific oversight for reagent generation, characterization, comparability, and stability
• Ensure appropriate documentation and traceability to support regulatory expectations
• Identify and evaluate external vendors for reagent generation and long-term supply
• Manage day-to-day CRO/CDMO interactions, including timelines, deliverables, and issue resolution
• Monitor vendor performance and proactively mitigate risks to supply or quality
• Develop lifecycle plans for critical reagents from early research through clinical phases
• Support change management activities, including reagent bridging and comparability assessments
• Ensure reagents meet appropriate GxP requirements based on development stage
• Work with Preclinical Operations to establish contracts and work orders for critical reagent generation
• Establish and manage active inventory to ensure consistent material traceability and availability for use across cross-functional teams and external partners
• Lead reoccurring cross functional discussions around strategy and ongoing campaign updates
• Cross-Functional Collaboration: Partner with Bioanalytical, CMC, Nonclinical, Clinical, Regulatory, Research, Legal, and Quality teams to align reagent strategies with program needs

Qualifications

• MS in Biology, Biochemistry, Immunology, Pharmaceutical Sciences, or related discipline with 3+ years of industry experience; or BS with 5+ years
• Direct experience generating and/or developing critical reagents (e.g., monoclonal antibodies, PK/ADA/NAb assay reagents, biomarkers, reference standards)
• Experience working with external CROs/CDMOs
• Strong understanding of bioanalytical assay development and reagent qualification
• Strong understanding of GLP/GCLP/GMP requirements as applicable to reagent use
• Working knowledge of regulatory expectations for critical reagents supporting INDs and clinical programs