Senior QC Scientist I

Posted 20 Days Ago
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Fremont, CA, USA
In-Office
150K-165K Annually
Senior level
Biotech
The Role
Lead QC for NULISAseq antibody pool production: perform in-process and finished-goods QC, analyze complex NGS datasets, troubleshoot failures, author and execute controlled documents, support method qualification/transfer, and collaborate across Product Development, Quality, and Manufacturing to ensure release-ready products under ISO 13485/GMP standards.
Summary Generated by Built In

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 skilled and quality-driven Sr. QC Scientist I to join our Operations team in a role that begins with an intensive 6-month onboarding period embedded within our Product Development group. During this period, the Sr. QC Scientist will receive comprehensive training in Alamar’s NULISAseq platform, antibody pool production processes, and our suite of QC methodologies. Upon completing this training, the Sr. QC Scientist will transition to Operations, where they will be the primary owner of building, QC, and troubleshooting for Alamar’s NULISAseq antibody pools. This role sits at the intersection of scientific rigor and manufacturing discipline and is critical to ensure that every panel we release meets the highest standards of quality and performance.

Responsibilities
  • Develop deep understanding of the NULISAseq antibody pool formulation process and interpretation of the data generated.
  • Coordinate the production of NULISAseq antibody pools, including accurate pooling of all antibodies, using established protocols.
  • Perform in-process QC and finished goods QC on NULISAseq products.
  • Analyze complex, multi-analyte NGS datasets to evaluate product performance metrics; identify meaningful deviations and drive targeted investigations to root cause.
  • Troubleshoot pool QC failures using structured, data-driven root cause investigations in a timely manner to meet both production needs and quality standards.
  • Track and maintain records to support traceability and root cause analysis.
  • Author, review, and execute SOPs and batch records in compliance with ISO 13485 and/or GMP quality standards.
  • Collaborate with Tech Transfer Team on the establishment of QC strategies, including method qualification/validation, specifications setting, and method transfer for new and existing products. Support the generation of Certificates of Analysis (COAs) and release documentation for manufactured antibody pools.
  • Collaborate closely with Product Development, Quality, and Manufacturing teams to communicate QC outcomes, escalate failures, and drive continuous improvement.
  • Maintain an organized, controlled, and inspection-ready work area; enforce safe work practices and compliance expectations.
  • Contribute to the development and refinement of QC acceptance criteria and troubleshooting decision frameworks as new panels and lots are introduced.
Qualifications
  • PhD. in Biochemistry, Molecular Biology, Immunology, or a related discipline with 5+ years, OR M.S. with 8+ years of relevant industry experience.
  • Background in next-generation sequencing (NGS) and immunoassays; experience with proximity ligation, proximity extension, or related single-molecule or multiplexed protein detection platforms is a plus.
  • Demonstrated ability to analyze and interpret large, complex datasets, with proficiency to efficiently identify meaningful issues in the data.
  • Strong working knowledge of immunoassay QC principles, including signal characterization and failure mode analysis.
  • Exquisite attention to detail and an uncompromising commitment to quality — this role requires precision at every step, from in-lab execution to documentation to data review.
  • Experience writing and executing SOPs, batch records, and other controlled documents in a regulated environment (ISO 13485 or equivalent).
  • Excellent organizational and record-keeping skills; ability to maintain full traceability across raw materials, in-process steps, and finished goods.
  • Strong troubleshooting skills; able to work through complex, multi-variable failure modes systematically and with scientific rigor.
  • Effective communicator who can clearly convey QC findings and escalation needs to cross-functional partners.
Preferred Qualifications
  • Experience with antibody-oligonucleotide conjugation chemistry and quality assessment of conjugated products.
  • Familiarity with high-plex proximity-based immunoassays or other highly complex products.
  • Experience with automated liquid handling platforms, particularly Hamilton, and automated assay systems.
  • Proficiency in data analysis tools such as R, Python, or JMP for processing NGS-based QC data.
  • Experience supporting or leading root cause investigations and CAPA processes in a quality system context.

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. 

Please Note - We participate in E-Verify to confirm authorization to work in the United States.

Skills Required

  • PhD in Biochemistry, Molecular Biology, Immunology, or related discipline with 5+ years OR MS with 8+ years of relevant industry experience.
  • Background in next-generation sequencing (NGS) and immunoassays.
  • Demonstrated ability to analyze and interpret large, complex datasets to identify meaningful issues.
  • Strong working knowledge of immunoassay QC principles, including signal characterization and failure mode analysis.
  • Experience writing and executing SOPs, batch records, and other controlled documents in a regulated environment (ISO 13485 or equivalent).
  • Exquisite attention to detail, excellent organizational and record-keeping skills, and full traceability across materials and products.
  • Strong troubleshooting skills and ability to perform data-driven root cause investigations in a timely manner.
  • Effective communication skills to convey QC findings and escalate issues to cross-functional partners.
  • Experience with antibody-oligonucleotide conjugation chemistry and quality assessment of conjugated products.
  • Familiarity with high-plex proximity-based immunoassays or other highly complex platforms (proximity ligation/extension).
  • Experience with automated liquid handling platforms (particularly Hamilton) and automated assay systems.
  • Proficiency in data analysis tools such as R, Python, or JMP for processing NGS-based QC data.
  • Experience supporting or leading root cause investigations and CAPA processes in a quality system context.
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The Company
HQ: Fremont, CA
69 Employees
Year Founded: 2018

What We Do

Alamar Biosciences is powering precision proteomics with automated, high throughput solutions for ultra-high sensitivity protein analysis across a range of multiplex levels. Our proprietary NULISA™ Chemistry utilizes a novel sequential capture and release method that significantly reduces background signal and increases the sensitivity and dynamic range compared with standard approaches and allows both qPCR and NGS readouts. The NULISAseq Inflammation Panel contains 200+ important markers related to immune and inflammatory diseases and will run on our ARGO™ System. This innovative platform allows for a fully automated workflow with less than 30 minutes hands on time from sample to data

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