Scientist, Reagent Manufacturing & Quality Control

The Scientist, Reagent Manufacturing & Quality Control (QC), is responsible for the production, characterization, and release testing of enzymes and critical reagents to support internal R&D activities and external diagnostic kit manufacturing, including in vitro diagnostic (IVD) products. This role is instrumental in ensuring that reagents meet performance, quality, and regulatory requirements.

The position is highly hands-on and requires execution of controlled manufacturing processes, analytical testing, and rigorous documentation practices to support design control, traceability, and regulatory compliance. The scientist will work cross-functionally to support assay development, verification/validation activities, and manufacturing readiness.

Key Responsibilities

IVD Reagent Manufacturing

• Prepare and manufacture buffers and reagents under controlled processes to support IVD product development and commercial manufacturing
• Execute batch production with full traceability, including raw materials, lot tracking, and process documentation
• Support scale-up and technology transfer activities for reagent manufacturing

Protein Expression & Purification

• Perform recombinant protein expression and purification using validated workflows
• Ensure batch-to-batch consistency and reproducibility of critical reagents
• Support process characterization and robustness studies required for design and validation

Quality Control (QC) & Release Testing

• Perform QC and release testing of enzymes and reagents against defined specifications
• Generate, review, and approve QC data packages to support lot release
• Identify and investigate out-of-specification (OOS) or out-of-trend (OOT) results

Design Control & Validation Support

• Support reagent characterization studies for design verification and validation (V&V)
• Contribute to defining reagent specifications, acceptance criteria, and stability protocols
• Assist with preparation of technical documentation for regulatory submissions (e.g., CE-IVDR technical files)

Documentation, Traceability & Regulatory Compliance

• Maintain complete and accurate documentation in accordance with QMS requirements (e.g., ISO 13485, CE-IVDR)
• Ensure compliance with Good Manufacturing Practices (GMP) and controlled documentation systems
• Support deviation investigations, root cause analysis, CAPA, and change control processes
• Contribute to audit readiness (internal, notified body, and regulatory inspections)

Laboratory Operations & Equipment Management

• Operate, maintain, and qualify laboratory equipment used in reagent manufacturing and QC testing
• Maintain calibration, maintenance, and equipment logs in compliance with QMS requirements
• Manage inventory of raw materials, critical reagents, and consumables with appropriate controls

Cross-Functional Collaboration

• Collaborate with assay development, clinical, regulatory, and manufacturing teams to ensure reagent performance meets product requirements
• Support integration of reagents into validated IVD workflows
• Participate in risk assessments (e.g., FMEA) related to reagent performance and manufacturing processes

Required Qualifications

• B.S. or M.S. in Biochemistry, Molecular Biology, Protein Chemistry, or related field
• Minimum 3+ years of experience in reagent manufacturing, protein production, or QC testing in a regulated or semi-regulated environment
• Hands-on experience with protein expression and purification workflows
• Familiarity with analytical and QC methods (e.g., HPLC, qPCR, UV-Vis spectroscopy)
• Understanding of assay-critical reagent performance and variability drivers
• Working knowledge of documentation standards and quality systems
• Strong attention to detail, data integrity, and traceability
• Ability to execute within a controlled quality system and follow SOPs strictly
• Strong problem-solving and troubleshooting capabilities

• Effective communication in cross-functional and regulated environments
• Familiarity with reagent stability studies and shelf-life determination

Preferred Qualifications

• Experience in IVD product development, particularly under CE-IVDR or ISO 13485 environments
• Experience supporting design control, verification/validation (V&V), and technical documentation
• Experience with enzyme manufacturing for molecular diagnostics (e.g., NGS, PCR-based assays)
• Prior exposure to audits or regulatory inspections