Sr. Scientist, Critical Reagents
Neurocrine Biosciences
4 hours ago
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
About The Role
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. Provide technical leadership and hands-on oversight for the generation, characterization, qualification, and supply of critical reagents used in nonclinical and clinical studies.
Your Contributions (include, But Are Not Limited To)
- 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
- Lead recurring cross-functional discussions around strategy and ongoing campaign updates
- Cross-functional collaboration with Bioanalytical, CMC, Nonclinical, Clinical, Regulatory, Research, Legal, and Quality teams
Requirements
- 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
Compensation/Benefits
- Annual base salary range: $110,800.00–$151,000.00
- Annual bonus with target of 20% of earned base salary
- Eligibility for equity-based long-term incentive program
- Retirement savings plan (with company match); paid vacation/holidays/personal days; paid caregiver/parental and medical leave; health benefits (medical, prescription drug, dental, vision)
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. Provide technical leadership and hands-on oversight for the generation, characterization, qualification, and supply of critical reagents used in nonclinical and clinical studies.
Your Contributions (include, But Are Not Limited To)
- 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
- Lead recurring cross-functional discussions around strategy and ongoing campaign updates
- Cross-functional collaboration with Bioanalytical, CMC, Nonclinical, Clinical, Regulatory, Research, Legal, and Quality teams
Requirements
- 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
Compensation/Benefits
- Annual base salary range: $110,800.00–$151,000.00
- Annual bonus with target of 20% of earned base salary
- Eligibility for equity-based long-term incentive program
- Retirement savings plan (with company match); paid vacation/holidays/personal days; paid caregiver/parental and medical leave; health benefits (medical, prescription drug, dental, vision)