Scientist, Reagent R&D and Manufacturing

Job Description

Job Description

We are seeking a highly motivated Scientist, Reagent R&D and Manufacturing to join our growing team developing innovative molecular diagnostic products. In this role, you will drive the development, characterization, validation, and manufacturing of critical molecular biology reagents and quality control assays that support next-generation sequencing (NGS) and molecular testing applications. 

This is a highly cross-functional position that offers the opportunity to translate scientific innovation into commercial products by working across research, product development, manufacturing, quality, and regulatory functions. The successful candidate will play a key role in product verification and validation activities and contribute to CE-IVD/CE-IVDR-compliant product development programs. 

Key Responsibilities 

Research & Development 

• Develop, optimize, characterize, and validate molecular biology reagents, enzymes, and quality control assays. 

• Design and execute experiments involving PCR, nucleic acid extraction, cloning, recombinant protein expression and purification, and other molecular biology techniques. 

• Develop analytical and functional assays to evaluate reagent activity, specificity, stability, robustness, and lot-to-lot consistency. 

• Analyze experimental results, troubleshoot technical challenges, and generate clear technical reports and documentation. 

• Establish product specifications, acceptance criteria, and testing strategies to support product development and commercialization. 

• Support product verification, validation, risk management, and technical documentation activities in accordance with applicable regulatory requirements. 

• Collaborate with multidisciplinary teams to advance research concepts into scalable, manufacturable products. 

Manufacturing & Product Operations 

• Transfer developed reagent processes from R&D into routine manufacturing operations. 

• Perform hands-on manufacturing of molecular biology reagents and assay components. 

• Execute manufacturing and quality control activities in accordance with approved procedures, batch records, and product specifications. 

• Conduct in-process testing, final QC testing, and release testing to ensure product quality and performance. 

• Author and maintain SOPs, manufacturing procedures, test methods, specifications, batch records, and related documentation. 

• Ensure complete traceability of materials, manufacturing activities, testing results, and finished product lots. 

• Investigate manufacturing deviations, quality events, and assay performance issues, implementing corrective and preventive actions as appropriate. 

• Continuously improve manufacturing efficiency, process robustness, and product quality within a regulated environment. 

• Operate in compliance with the company Quality Management System (QMS), ISO 13485 requirements, GMP principles, and applicable CE-IVD/CE-IVDR regulations. 

Requirements

Education & Experience 

• Ph.D. in Molecular Biology, Biochemistry, Biotechnology, Bioengineering, or a related discipline. Recent Ph.D. graduates and candidates with 0–2 years of industry experience are encouraged to apply.

• M.S. in Molecular Biology, Biochemistry, Biotechnology, Bioengineering, or a related discipline with significant industry experience (8+ years) in molecular biology, reagent development, enzyme characterization, manufacturing, or related fields. 

Required Qualifications 

• Strong foundation in molecular biology, biochemistry, enzymology, or assay development. 

• Hands-on laboratory experience and willingness to work across both product development and manufacturing activities. 

• Demonstrated ability to design experiments, analyze data, troubleshoot complex technical problems, and draw sound scientific conclusions. 

• Excellent organizational, documentation, and technical communication skills. 

• Strong attention to detail and commitment to product quality, data integrity, and regulatory compliance. 

• Ability to thrive in a fast-paced, collaborative, and highly regulated environment. 

Preferred Qualifications 

• Experience in enzyme characterization, reagent development, or QC assay development. 

• Experience with NGS workflows, including library preparation and sample preparation technologies. 

• Experience with recombinant protein expression and purification. 

• Familiarity with analytical techniques such as HPLC, UV-Vis spectroscopy, electrophoresis, qPCR, and biochemical activity assays. 

• Experience working in ISO 13485, GMP, IVDR, IVD, or other regulated environments. Experience supporting technology transfer from development to manufacturing is a plus.