Senior Scientist I, Product Development

Alamar Biosciences, Inc.; Fremont (CA); On-site; USD 150,000 - 165,000; Full time

Benefits offered by this job

Bonus

Equity

Benefits

Job summary

Alamar Biosciences, Inc. in Fremont, California is seeking a motivated Sr. Scientist I to join the Product Development team. This role focuses on downstream product development, optimizing QC methods, and supporting new product introduction from R&D to manufacturing.

The ideal candidate will have a Ph.D. with relevant industry experience, a strong background in assay development, and skills in working within regulated environments.

Qualifications

• 5+ years of industry experience in QC method development.
• Experience with immunoassays and molecular assays.
• Strong documentation skills for SOPs and validation reports.

Responsibilities

• Design, develop, and optimize QC methods.
• Lead product and process transfer to Manufacturing.
• Collaborate with cross-functional teams.

Skills

QC method development

Problem-solving skills

Collaboration in teams

Statistical analysis tools

Assay development

Education

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

M.S. with 8+ years of relevant industry experience

Tools

Python

R

Job description

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.

Key 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.

Preferred Qualifications

• Experience with lyophilization or other freeze‑drying methods.
• Experience supporting process scale‑up and early‑stage manufacturing and QC.
• Familiarity with automation or high‑throughput workflows.
• Programming or data analysis experience (Python or R).

Compensation

The base salary range for this full‑time position is $150,000 - $165,000 + bonus + equity + benefits.