Alamar Biosciences
Senior Scientist I, Product Development
Fremont, California · Senior
Sponsorship not specifiedDetected 34 days ago
Process ImprovementMolecular Biology
About the role
- Scientist I to join the Product Development team supporting New Product Introduction (NPI).
- This role focuses on downstream product development, including QC method development, analytical strategy, process optimization, and transfer of assays and reagents from R&D into Manufacturing.
- The Product Development team operates at the interface of R&D and Operations and is responsible for ensuring products are robust, scalable, and manufacturable.
Responsibilities
- Design, develop, and optimize QC methods to characterize assay performance, reagent quality, and product consistency
- Design and execute V&V studies including precision, sensitivity, linearity, and robustness testing
- Support end-to-end product development from late-stage R&D through commercialization
- Lead or support product and process transfer to Manufacturing, including documentation and training
- Develop scalable and robust production processes for complex assay and reagent systems
- Collaborate with R&D, Manufacturing, QC, Quality, and Engineering teams
- Lead or support root cause investigations and continuous improvement initiatives
Requirements
- Ph.D. in Biochemistry, Molecular Biology, Immunology, or a related discipline with 5+ years OR M.S. with 8+ years of relevant industry experience
Skills
- Define QC strategies across the product lifecycle, including raw material, in-process, and finished goods QC
- Troubleshoot process and QC issues during transfer and early manufacturing runs
- Author SOPs, validation reports, and transfer documentation
- Deep expertise in QC method development, validation, and transfer to manufacturing
- Experience leading NPI and product transfer efforts f or commercially successful biotech tools or diagnostic products
Company info
- We are seeking a highly motivated Sr.
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