Senior QC Scientist I

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

• D. 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.