Scientist - Product Development

Company: Exokeryx
Location: Fremont
Posted on: February 18, 2025

Job Description:

At Alamar Biosciences, we're on a mission to transform the field of proteomics for the early detection of cancer and other diseases. We are creating the world's most sensitive proteomics platform to unmask the deepest secrets of our proteome. Our fully automated, high throughput platform will empower new biomarker discoveries for early detection and prevention of common diseases. We provide exceptional opportunities for those who have the entrepreneurial spirit, enjoy developing novel technologies and products, and aspire to grow together with the company.We are seeking a Product Development Scientist, with a focus on verification and validation (V&V) and QC method development. You will be working in a fast-paced environment, on multiple projects, and will be a part of a rapidly growing company to make a big impact in life science research and early disease diagnosis.

Primary Responsibilities include:

• Design, execute and analyze verification and validation (V&V) studies to characterize the performance of assay reagents per CLSI guidelines
• Perform reagent and assay robustness and stability studies
• Develop QC test methods for assay reagents and manufactured products
• Support the reagent/instrument integration, including process engineering studies
• Characterize prototype NULISA-- system performance to support commercial launch
• Prepare summaries, internal reports, presentations, manuscripts, etc
• Collaborate with cross-functional teams to ensure the timely and accurate completion of deliverables
• Contribute to the development and documentation of technology and product requirements, protocols, and work instructions, ensuring clarity and compliance with industry standards
• Perform other duties and assumes additional departmental responsibilities as requiredQualifications include:
  • Ph.D. degree in Molecular Biology or a related field with 2+ years
  • Expertise in molecular assay design and development,reagent storage stability studies, developing and validating QC test methods, and defining product, process, and material specifications
  • Solid conceptual framework and hands-on experience in molecular biology methodology development, including PCR, Taqman qPCR and next-gen sequencing (NGS)
  • Experience in IVD product development with ELISA immunoassay is a plus
  • Proficient technical writing skills and excellent documentation skills for experimental work and data analysis
  • Working knowledge of statistical analysis and proficiency in data analysis tools such as JMP and R are desirable
  • Experience in Industry, preferably having developed and transferred products to a manufacturing settingWe offer a competitive and comprehensive employee benefits package, including daily lunch, health, dental, vision, life insurance, a flexible spending plan, paid vacation, stock options and a 401(k) plan. The base salary range for this full-time position is $120,000 - $145,000 + bonus + equity + benefits. Our salary ranges are determined by work location, job-related skills, experience, and relevant education or training.
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Keywords: Exokeryx, Fremont , Scientist - Product Development, Other , Fremont, California