Provide strong technical support and activity management to CROs and R&D colleagues
Evaluate assay development (AD) and sample testing vendors for suitability to conduct clinical phase-appropriate AD and testing activities.
Develop and implement assays for clinical and nonclinical vaccine study applications, including human Phase 2 and Phase 3 trials and NHP studies.
Implement assays that measure antigen-specific cellular and humoral immune responses and deploy these to better understand the mechanism of action of Sabin’s vaccines.
Design analytical assay qualification and validation protocols and work closely with vendors to guarantee their accurate execution.
Manage related assay tech transfers and review validation reports.
Author technical responses to assays-specific questions and directives from regulatory authorities and stakeholders.
In collaboration with clinical and statistical SMEs, review, draft, and revise assay related sections of data transfer agreements, statistical analysis protocols (SAPs), SOPs, and study reports.
Collaborate with assays vendors and clinical CROs to ensure the seamless transfer of immunological samples (blood, cells, serum/plasma) between clinical sites and vendors located on different continents.
Work with clinical testing vendors to ensure GLP-compliant assay execution and documentation.
Maintain internal operational documents under GxPs, adhering to best practices concordant with Phase 3 and commercial level of vaccine regulatory compliance.
Work with clinical team members to ensure GCP-compliant data analyses, adherence to blinding protocols, and stewardship over clinical immunology samples (e.g., serum and PBMCs) and assay data.
Collaboratively support the design/ and implementation an immune correlate of protection testing strategy for NHPs that supports the animal rule-based approach to vaccine licensure
Devise, maintain and guide the implementation of best practices such establishing/certifying the appropriate compliancy level for a matrix of assays used in NHP studies
Participate in the drafting and review of study reports, SOPs, SAPs, and publications of NHP study outcomes
Work closely with the Translational R&D leadership to provide assay-related expertise for NHP and other animal studies to efficiently develop and characterize mechanistic immunological assays needed for animal rule-based licensure strategies:
Provide assay support for the design and execution of experiments that lay groundwork for NHP to human immunobridging
Further characterize immune correlates of protection
Assess the relevance and rigor of current experimental approaches and assay methods; improve immunogenicity evaluation strategies
Facilitate cross-functional planning of assays activities to align on schedules, dependencies, and funding to support phase 2 and 3 trial completion and licensure.
Work with project management to operationalize experimental and assays goals and associated timelines, budgets, and risk mitigation strategies.
Facilitate data collection, quality control, organization, and analysis to strengthen the data infrastructure of the Translational R&D team
Participate in meetings with consultants, partners and funders, including biweekly meetings with the Biomedical Advanced Research and Development Authority (BARDA); prepare and present assays-related meeting materials
Serve as a subject matter expert for immune assays for communications with funders and global health stakeholders (e.g., WHO, Gavi, Coalition for Epidemic Preparedness Innovations (CEPI), and related)
Participate in the preparation of grant applications, contracts and other fundraising efforts

Requirements

Minimum Bachelor’s degree in immunology (preferred), biochemistry, molecular/cellular biology, virology, or related discipline.
Minimum of 10 years’ analytical assay development, with hands on experience with immunological assay development, tech transfer, verification, qualification, and validation
Track record of developing and deploying cellular and humoral immune assays including the following ELISA Pseudovirus-based neutralization assays ELISpot Intracellular Cytokine staining
Experience conducting ex-vivo/in-vitro immune analyses on cells/tissues/blood harvested from animals and/or from human subjects
Analytical qualification/validation of immunological assays per ICH standards
Publishing immunological assays data in peer-reviewed journals and/or direct contributions to licensed vaccines or other biologicals.
In-depth understanding of US regulations and a comprehensive working knowledge of current Good Laboratory Practices (GLPs) and regulatory guidance related to Phase 2 and Phase 3 product development, sample handling and testing
Hands on experience conducting or managing immune sample testing for phase 2 and phase 3 FDA-regulated human clinical trials
Experience working in project teams with or within clinical and nonclinical CROs
Enthusiasm for problem solving, discovery, and knowledge enrichment
Comprehensive grasp of the inter-disciplinary nature of vaccine development, demonstrated with successful vaccine development through Phase 3 trials
Ability to manage complex tasks, prioritize competing objectives and work well under pressure, maintaining clear purpose and attention to detail
Exemplary verbal and written communication and presentation skills; ability to distill technical information to digestible concepts for partners of varied technical backgrounds
Team player with time-proven interpersonal skills, consistently showing respect and appreciation of co-workers and colleagues
Ability to travel frequently domestically and internationally with notice

Benefits

Medical, Dental, Vision and Flexible Spending Accounts
Employer paid, Life and Disability insurance
11 paid holidays with a winter break between Christmas and New Years
Employer match on 401(k)

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

analytical assay developmentimmunological assay developmenttech transferverificationqualificationvalidationELISAPseudovirus-based neutralization assaysELISpotIntracellular Cytokine staining

Soft Skills

problem solvingdiscoveryknowledge enrichmenttask managementprioritizationattention to detailverbal communicationwritten communicationpresentation skillsinterpersonal skills