){kind=logo}
About the Role Hims & Hers is seeking a Senior Scientist, R&D to join our growing laboratory organization. The role is an individual contributor reporting to the Director of R&D and focuses on developing and validating diagnostic assays for both traditional and at-home testing programs, as well as supporting assay implementation into clinical operations. This on‑site laboratory position is based in Central New Jersey. You Will Assay Development and Validation Design and execute immunoassay development, optimization, and verification studies including ELISA, chemiluminescent, and multiplex formats. Perform method validation experiments such as precision, accuracy, linearity, interference, and stability testing per established protocols. Apply Design of Experiments (DOE) and statistical methodologies to assay optimization and troubleshooting. Support LC‑MS/MS method development and validation for clinical chemistry and hormone analytes. Evaluate performance characteristics of capillary versus venous specimens, investigate interference, and develop strategies to extend sample stability. Develop and revise SOPs to support consistent, reproducible laboratory operations. Prepare validation summaries, protocols, and technical reports in compliance with quality and regulatory standards. Laboratory Execution Perform hands‑on laboratory testing using specimens collected via at‑home devices such as Tasso and YourBio Health, including whole blood, plasma, serum, and other biological matrices. Operate LC‑MS/MS instrumentation (SCIEX 4500MD or equivalent) including sample preparation, method validation, and data review. Support testing on automated chemistry and hematology platforms including Roche Cobas Pro and Sysmex systems, covering CBC and whole blood analyte workflows. Support liquid handling automation workflows for sample processing and high‑throughput laboratory operations. Troubleshoot assay performance issues across immunoassay, clinical chemistry, mass spectrometry, and molecular diagnostic platforms. Data Analysis Analyze experimental data and perform statistical evaluation of assay performance including precision, bias, and total allowable error modeling. Prepare figures, tables, and technical summaries for internal review and scientific communication. Contribute to peer‑reviewed publications and scientific conference presentations. Quality and Regulatory Collaboration Partner with the Quality team to ensure study designs and documentation meet CAP, CLIA, and applicable regulatory requirements. Support investigation and resolution of sample rejection issues to improve overall laboratory quality metrics. Support laboratory inspection readiness and audit preparation activities. Collaborate with Clinical Laboratory Operations during assay transfer and implementation. You Have PhD in Clinical Chemistry, Biochemistry, Analytical Chemistry, Molecular Biology, or related field with 4+ years; or Master's degree with 7+ years; or Bachelor's degree with 10+ years of relevant bench experience in a diagnostic or clinical laboratory setting. Demonstrated hands‑on experience in immunoassay development including singleplex and multiplex formats. Experience with LC‑MS/MS instrumentation, including sample preparation and method validation. Experience with capillary and venous blood‑based specimen types. Demonstrated experience leading assay validation and verification studies. Experience applying DOE and statistical methodologies to assay development and optimization. Proven ability to work independently and drive projects from concept to completion. Preferred Experience in a CAP and/or CLIA regulated laboratory environment. Experience with at‑home or point‑of‑care diagnostic testing programs. Experience with dried blood spot (DBS) workflows and stability characterization. Familiarity with emerging biomarker categories. #J-18808-Ljbffr
Senior Scientist, R&D - Assay Development • South Plainfield, NJ, United States
Executive Director, Oncology Global Clinical Development.Our Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drug... Show more
We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world.Advancing the world of health is our Purpose, and it's no small feat.It t... Show more
Description: Sr Scientist Product Development R&D We are seeking an independent and motivated Scientist to join the Product Development R&D team.This role will report into Product Development in th... Show more
Senior Director of Research & Development for Worldwide Infusion Preparation and Delivery Platform.BD is one of the largest global medical technology companies in the world.Advancing the world of h... Show more
We are seeking a skilled and motivated Senior Biostatistician to join our fast-moving, collaborative environment focused on medical imaging and dermatology-based clinical development.In this role, ... Show more
Ardena is a global Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) specializing in precision medicine development.Ardena supports pharmaceutical ... Show more
Scientist II, Specialty Formulations R&D, Denville, NJ: Support in the dev.Full understanding of FDA regs.ANDA, IND/NDA processes, & Good Mfg.Ability to prform phrmceutical calculations.CPP & CQAs ... Show more
Axtria's Decision Intelligence team is undergoing a significant transformation, integrating Artificial Intelligence (AI) and Generative AI (GenAI) into our solutions.We are seeking an Advanced Anal... Show more
The Senior Medical Director provides strategic and scientific leadership for one or more development programs and serves as the clinical development lead from early development through registration... Show more
Senior Specialist, R&D Insights.Established in 1806 as a small soap and candle business in New York City, Colgate-Palmolive is now a truly global company with products sold in over 200 countries an... Show more
We Are The People Who Give Possibilities Purpose.BD is one of the largest global medical technology companies in the world.Advancing the world of health™ is our Purpose, and it’s no small feat.It t... Show more
AI data lab for training frontier models and evaluating AI agents.Experts contribute their diverse subject matter knowledge across domains such as finance, healthcare, STEM engineering, and more.AI... Show more
We're here for one reason and one reason only to cure cancer.Every moment is dedicated to developing treatments and every action moves us one step closer to our goal.We've made incredible scientif... Show more
Experience Design Strategy Senior Manager.The Experience Design Strategy Senior Manager is a client-facing consulting leader responsible for delivering high-impact experience design strategy engage... Show more
With supervision, oversees the direction, planning, execution and interpretation of clinical trials or research activities of a clinical development program.Participates in cross-functional teams t... Show more
Vice President, Translational & Computational Pathology.Rapidly growing oncology-focused biotechnology company advancing precision medicine and companion diagnostics.The Company is seeking a VP, Tr... Show more
Process Modeling, Product Engineering teams.Equity grant reflecting the seniority and trust of the role.Still Bright is bringing the first viable hydrometallurgical alternative to copper smelting t... Show more
PRINCIPAL RF/MICROWAVE ENGINEER – Paterson, NJ.Dvelop trnsformer-free RF stage architctures; cnduct rsearch, mdeling, vlidation & dsign high dnamic range/low noise diffrntial mixers; design RF/mcro... Show more
Category Laboratory Location Old Bridge, New Jersey Job function Operations Job family Laboratory Operations Shift Day Employee type Regular Full-Time Work mode On-site Job Description Medical L... Show more
The Analytical Science Manager-Technical Operations provides critical technical expertise to support analytical method related activities for both drug substance and drug products.Reporting directl... Show more
){kind=logo}
