IVD Reagent Manufacturing & QC Scientist

AccuraGen; Milpitas (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

AccuraGen seeks a Scientist for Reagent Manufacturing & QC to drive production, characterization, and release testing of enzymes and critical reagents for internal R&D and external diagnostic kit manufacturing.

The role emphasizes hands-on manufacturing, analytical testing, and rigorous documentation to meet design control, traceability, and regulatory requirements across ISO 13485/CE-IVDR contexts.

Qualifications

• B.S./M.S. in a life sciences discipline as listed.
• Minimum 3+ years in reagent manufacturing, protein production, or QC testing.
• Hands-on protein expression and purification experience required.
• Familiarity with QC analytical methods and documentation standards.

Responsibilities

• Manufacture buffers and reagents under controlled processes with traceability.
• Perform recombinant protein expression and purification workflows.
• Execute QC and release testing of enzymes and reagents per specs.
• Support design verification/validation and regulatory documentation.
• Maintain GMP-compliant documentation, deviations, and CAPA records.
• Collaborate cross-functionally to ensure reagent performance and data integrity.

Skills

Reagent manufacturing

Protein expression

QC testing

Documentation

Analytical methods

Problem solving

Cross-functional comms

Education

B.S. or M.S. in Biochemistry, Molecular Biology, Protein Chemistry, or related field

Tools

HPLC

qPCR

UV-Vis spectroscopy

Job description

AccuraGen seeks a Scientist for Reagent Manufacturing & QC to drive production, characterization, and release testing of enzymes and critical reagents for internal R&D and external diagnostic kit manufacturing.

The role emphasizes hands-on manufacturing, analytical testing, and rigorous documentation to meet design control, traceability, and regulatory requirements across ISO 13485/CE-IVDR contexts.