Senior Scientist I, Product Development

Alamarbiosciences; Fremont (CA); On-site; USD 150,000 - 165,000; Full time

Benefits offered by this job

Bonus

Equity

Health benefits

Job summary

Alamarbiosciences is looking for a highly motivated Sr. Scientist I in Fremont, California, to join the Product Development team. This role is centered on QC method development, ensuring products are robust and manufacturable, while supporting New Product Introduction.

The ideal candidate will possess a Ph.D. with over 5 years of relevant experience or an M.S. with 8+ years, featuring strong expertise in analytical strategy and interdepartmental collaboration. The role offers a competitive salary and benefits.

Qualifications

• Ph.D. in a relevant field with 5+ years or M.S. with 8+ years of experience.
• Deep expertise in QC method development and validation.
• Experience with immunoassays (e.g., ELISA) and molecular assays.

Responsibilities

• Design and optimize QC methods and strategies.
• Support product development from R&D to commercialization.
• Collaborate across teams on product and process transfers.

Skills

QC method development

Analytical strategy

Process optimization

Assay development

Team collaboration

Education

Ph.D. in Biochemistry, Molecular Biology or related discipline

Tools

Statistical analysis tools (e.g., JMP)

Job description

Position Summary

We are seeking a highly motivated Sr. 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.

Duties and Responsibilities

• Design, develop, and optimize QC methods to characterize assay performance, reagent quality, and product consistency
• Define QC strategies across the product lifecycle, including raw material, in-process, and finished goods QC
• 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
• Troubleshoot process and QC issues during transfer and early manufacturing runs
• Collaborate with R&D, Manufacturing, QC, Quality, and Engineering teams
• Author SOPs, validation reports, and transfer documentation
• Lead or support root cause investigations and continuous improvement initiatives

Qualifications

• Ph.D. in Biochemistry, Molecular Biology, Immunology, or a related discipline with 5+ years OR M.S. with 8+ years of relevant industry experience
• Deep expertise in QC method development, validation, and transfer to manufacturing
• Experience leading NPI and product transfer efforts for commercially successful biotech tools or diagnostic products
• Strong background in assay development, reagent formulation, and analytical methods
• Experience with writing technical documentation including SOPs and validation reports
• Strong problem solving and troubleshooting skills
• Experience with immunoassays (ELISA, MSD, Simoa) and molecular assays (qPCR, ddPCR, NGS)
• Experience working in IVD or regulated environments (e.g., ISO 13485)
• Familiarity with statistical analysis tools such as JMP
• Understanding of manufacturing and scale-up considerations
• Demonstrated ability to work effectively as a team player, collaborating openly and constructively within cross‑functional teams

The base salary range for this full‑time position is $150,000 - $165,000 + bonus + equity + benefits. Our salary ranges are determined by work location, job‑related skills, experience, and relevant education or training. The ranges displayed on each job posting reflect the minimum and maximum target for new hire salaries but are subject to change if the leveling of the role is adjusted. Your recruiter can share more about the specific salary range during the hiring process.

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