Director, Reagent Development

The Position

We are seeking a highly driven and experienced Director of NGS Reagent Development to lead a dedicated team of development scientists in design, development, and optimization of NGS reagents specifically for use within our clinical laboratory products.

Key Responsibilities

• Leadership & Team Management
  Direct, mentor, and grow a team of research and development scientists, fostering a culture of scientific rigor, innovation, and continuous improvement.
  Define project goals, allocate resources, and manage timelines to ensure assay and reagent development milestones align with product and clinical laboratory needs.
  Provide technical guidance and troubleshooting support for complex biochemical and molecular challenges encountered during reagent optimization.

• NGS Reagent Development
  Lead the end-to-end development, formulation, and optimization of enzymes, buffers, and chemical reagents for internal NGS applications (e.g., library preparation, target enrichment, sequencing chemistries).
  Design and execute robust verification and validation (V&V) studies tailored for the manufacturing workflows.
  Establish critical quality attributes (CQAs) and stability testing protocols for raw materials and finished reagents.

• Quality & Compliance (GMP / ISO 13485)
  Ensure all reagent development and internal manufacturing activities strictly comply with ISO 13485 standards, Good Manufacturing Practices (GMP), and our internal Quality Management System (QMS).
  Oversee the generation of meticulous design control and validation documentation, including standard operating procedures (SOPs), batch records, and quality control specifications required for CLIA/CAP compliance.
  Lead technical design reviews and phase-gate meetings for internal deployment.

• Cross-Functional Collaboration
  Partner closely with Product Development, Operations, Quality Assurance, and Supply Chain teams to ensure seamless design transfer, scale-up, and internal production of NGS reagents.
  Collaborate with Bioinformatics team to ensure reagent specifications meet required assay performance metrics and turnaround times.

Who You Are

• Education & Background
  Ph.D. in Biochemistry, Molecular Biology, Chemistry, or a closely related discipline.
  10+ years of industry experience in life sciences, biotechnology, or clinical diagnostics, with at least 5+ years in a management or leadership role.

• Technical Expertise
  Deep Biochemistry Knowledge: Proven track record of developing and optimizing complex biochemical systems, enzymology, and nucleic acid interactions.
  NGS Mastery: Extensive hands-on experience developing reagents, kits, or assays specifically for Next-Generation Sequencing
  Reagent Development Lifecycle: Demonstrated success development of least one NGS reagent or relevant formulation from concept through design transfer and manufacturing implementation.

• Regulatory & Quality Experience
  GMP/ISO Regulated Environments: Direct experience developing products under strict design control processes within an ISO 13485 and/or cGMP compliant environment.
  Clinical Lab Standards: Familiarity with CLIA/CAP guidelines and the specific quality and regulatory requirements for scaling reagents within a high-throughput clinical laboratory.
  Expertise in Design of Experiments (DoE), statistical analysis, and establishing rigorous QC metrics for reagent formulation.

Preferred Skills

• Excellent cross-functional communication and presentation skills.
  Strong strategic thinking paired with a willingness to "roll up your sleeves" and engage with the science.
  Experience managing raw material supply chains and interacting with external vendors for critical reagent components.