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