Overview Goldbelt Professional Services specializes in providing expert resources for Public Health missions including scientific, technical, and administrative support from junior staff to high-level subject matter experts. Research and data driven, Goldbelt Professional Services’ experts create solutions customized to the client’s needs. Summary: The Assay Specialist (Process Advisor) for the JPM CBRN Task Order 3 contract in the CTO Program Office serves as the technical point of contact for assay development, qualification, and validation efforts, and provide technical and planning oversight and support to multiple priorities with aggressive timelines. Responsibilities Essential Job Functions: The contractor shall ensure appropriate subject matter experts are involved in the day-to-day management of manufacturing efforts. The contractor shall manage projects for multiple programs and projects across the portfolio The contractor shall serve as the subject matter expert in CMC and non-clinical (pre-clinical)/clinical (humoral and cell-mediated) analytical methods, supporting stakeholder groups in resolution to investigations related to these methods. The contractor shall provide detailed guidance on all aspects of manufacturing, preclinical/non-clinical, and clinical assay development, qualification, and validation which may include assessments in various assay characteristics (i.e., accuracy, precision, dilutional linearity, range, LOD, LOQ, selectivity, specificity, robustness, and stability). The contractor shall develop approaches to enhance CMC, preclinical, and clinical/non-clinical assay capabilities by providing detailed guidance on processes to eliminate failure modes and deficiencies. The contractor shall serve as the technical interface between pre-clinical/nonclinical, clinical, and CMC stakeholders in order to establish, define, and validate CMC, preclinical/non-clinical, and clinical assays, and to ensure compliance with regulatory and quality guidelines. The contractor shall perform data-level technical and quality reviews of assay results and implications/interpretations to ensure technical and scientific data integrity and adherence to compliance with appropriate regulatory standards. The contractor shall review all aspects of testing and data analysis, detailing recommendations and guidance on paths forward for experimental design and execution, data evaluation, assay optimization and validation, and documenting assay development progress. The contractor shall develop and/or review qualification test plans for critical reagents, materials, and equipment used in analytical methods. The contractor shall review and comment on technical protocols, validation plans, and regulatory submissions related to assay efforts in order to identify direct and indirect impacts to validation efforts and determine whether appropriate documentation is being appropriately generated, reviewed, and approved during design development. The contractor shall provide subject matter expertise to other intergovernmental partners and serve as liaison to the Technology Base (i.e., DTRA, USAMRIID, WRAIR, and HHS partners). The contractor will assess results and progress relative to objectives across projects and communicate periodically/as needed to relevant leadership and stakeholders. The contractor shall remain flexible to change priorities and ideas while keeping project milestones on track. The contractor shall propose and implement solutions to critical problems by creating actionable strategies and implementation plans to reallocate resources or efforts as required, as well as oversight plans that use metrics for monitoring progress. The contractor shall conduct required site visits of performers to assist in monitoring performance and quality standards, provide technical oversight, and assess capabilities and program progress. The contractor shall lead focused working groups and provide detailed summaries (i.e., develop meeting minutes and track action items). The contractor shall serve as the technical representative at conferences and stakeholder meetings. The contractor shall draft reports, including executive summaries, manuscripts, and other technical documents. Qualifications Necessary Skills and Knowledge: Shall possess an understanding of regulatory and quality compliance requirements. Shall possess experience independently designing studies, as well as an ability to think critically and solve complex technical problems. Shall possess state-of-the-art knowledge on all aspects of assay technology innovation, product development, and product enhancements. Shall possess a broad knowledge of the theory of operation and application of advanced bio-analytical assay methods and platforms (e.g., enzymatic, immunochemical, chromatographic, radiometric, mass spectrometric, ECL, PCR, SPR, etc.). Shall possess a familiarity with statistical methods and data analysis software. Shall be capable of working independently and as part of a team. Shall possess strong analytical and problem solving skills, as well as good organization skills to balance and prioritize work. Shall be highly motivated, with great attention to detail and an ability to deliver results in a fast paced environment. Shall possess strong interpersonal and communication skills, both oral and written. Proficiency with Microsoft Office, to include Outlook, Project, PowerPoint, Excel, and Word. Minimum Qualifications: Shall possess a PhD in Chemistry, Organic Chemistry, Biology, or a related discipline, as well as fifteen (15) years of general experience and ten (10) years of relevant experience. Tradeoff Requirement: The contractor shall possess a Master’s degree in Chemistry, Organic Chemistry, Biology, or a related discipline, as well as twelve (12) years of general experience and eight (8) years of relevant experience. Possess a familiarity and experience with ICH and regulatory guidelines as applied to analytical aspects (i.e., FDA GLP and/or GMP). Possess experience in a regulated (i.e., GLP/GCP/GMP/CLIA) laboratory environment. Minimum of seven (7) years of experience conducting and developing manufacturing, preclinical, or clinical assays to support product licensure (with a preference for prior experience with all). Experience developing and validating (i.e., GLP/GMP) analytical and/or bio-analytical test methods. Clearance: Secret Pay and Benefits The salary range for this position is $150,000 to $175,000 annually. At Goldbelt, we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.