Scientist I, Product Development bei Alamar Biosciences
Alamar Biosciences · Fremont, Vereinigte Staaten Von Amerika · Hybrid
- Optionales Büro in Fremont
At Alamar, we are passionate about enabling our customers to make scientific discoveries that translate into clinical outcomes and benefit patients. Our team is growing quickly as we develop innovative approaches to measure critical protein biomarkers from liquid samples that can enable the earliest possible detection of disease. We believe the next frontier in biology is enabled by measuring proteins at higher sensitivity in highly multiplexed assays at the push of a button, which is something only Alamar can do. As we build our team, we seek collaborative, driven, intellectually curious people committed to solving complex challenges. Our culture rewards accountability and cross functional teamwork because we believe this enables the kind of breakthrough thinking that will accelerate our mission.
We are seeking a highly motivated Scientist I to join the Product Development team supporting New Product Introduction (NPI) as we rapidly build our ambitious commercial portfolio. You will play a critical role in transitioning assays and reagents from R&D concepts into commercially viable products. This individual will be responsible for assay transfer, analytical readiness, technical risk mitigation and ensuring all new products are manufacturable, scalable and robust.
Key Responsibilities
- Lead the transfer of assay designs from R&D into manufacturing, including preparation of technical transfer documentation and training materials.
- Design and execution of verification and validation (V&V) studies, including precision, linearity, sensitivity (LoD/LoQ), interference, stability, and robustness testing.
- Develop product level QC strategies and design, optimize, and implement novel QC assays to ensure product quality
- Identify and troubleshoot assay or process issues, recommend solutions, and contribute ideas for assay and process improvements.
- Perform data analysis and generate study reports suitable for design review.
- Collaborate closely with R&D, Manufacturing, QC, Engineering, Quality, and Commercial teams to support NPI milestones and timelines.
- Perform other duties as required
Requirements
- Ph.D. in Biochemistry, Molecular Biology, Immunology, or a related discipline with 0-2+ years of relevant biotech industry experience; B.S/M.S. with 4+ (M.S.) or 6+ (B.S.) years of experience will also be considered.
- Demonstrated experience with NPI as evidence by a hands-on role in the transfer and launch of a complex commercially available biotech product
- Experience in developing and validating immunoassays such as ELISA.
- Experience with high-sensitivity immunoassay platforms (Simoa, MSD, or Luminex) is a plus but not required.
- Understanding of verification and validation study design and execution using CLSI guidelines
- Hands on experience in QC assay design including the determination of appropriate metrics and specifications
- Familiarity with molecular biology methods (e.g., qPCR, ddPCR, NGS).
- Demonstrated ability to proactively lead and independently drive complex technical initiatives and take ownership of challenging problems.
- Strong problem-solving and analytical skills with attention to detail in experimental design and execution.
- Proficiency in data analysis and experimental design tools (JMP or other statistical software).
- Strong communication skills, including data presentation and technical documentation.
- 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 $120,000 - $140,000 + 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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