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