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.
Numbers & Facts
Location
Fremont, CA
Skills
Analysis Skillsunmatched
Antibodiesunmatched
Assaysunmatched
Biochemistryunmatched
Chemistryunmatched
Communication Skillsunmatched
Continuous Improvementunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Cross-Functionalunmatched
Data Analysisunmatched
Data Setsunmatched
Detail Orientedunmatched
Document Managementunmatched
Documentationunmatched
Embedded Systemsunmatched
Failure Analysisunmatched
GMP (Good Manufacturing Practices)unmatched
ISO (International Organization for Standardization)unmatched
Identify Issuesunmatched
Immunoassaysunmatched
Immunologyunmatched
Manufacturingunmatched
Molecular Biologyunmatched
Next Generation Sequencing (NGS)unmatched
Onboardingunmatched
Organizational Skillsunmatched
Performance Metricsunmatched
Process Improvementunmatched
Product Developmentunmatched
Product Supportunmatched
Product Testingunmatched
Python Programming/Scripting Languageunmatched
Quality Controlunmatched
Quality Control Methodologyunmatched
Quality Metricsunmatched
R Programming Languageunmatched
Record Keepingunmatched
Root Cause Analysisunmatched
Safety/Work Safetyunmatched
Standard Operating Procedures (SOP)unmatched
Strategic Planningunmatched
Structured Dataunmatched
Testingunmatched
Time Managementunmatched
Traceabilityunmatched
Writing Skillsunmatched
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