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 manufacturingExecute batch production with full traceability, including raw materials, lot tracking, and process documentationSupport 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 reagentsSupport 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 releaseIdentify 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 protocolsAssist 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 systemsSupport deviation investigations, root cause analysis, CAPA, and change control processesContribute 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 requirementsManage 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 requirementsSupport integration of reagents into validated IVD workflowsParticipate in risk assessments (e.g., FMEA) related to reagent performance and manufacturing processes Requirements 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 driversWorking knowledge of documentation standards and quality systemsStrong attention to detail, data integrity, and traceabilityAbility to execute within a controlled quality system and follow SOPs strictly Strong problem-solving and troubleshooting capabilitiesEffective 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 environmentsExperience supporting design control, verification/validation (V&V), and technical documentationExperience with enzyme manufacturing for molecular diagnostics (e.g., NGS, PCR-based assays)Prior exposure to audits or regulatory inspections