Director, Technology and Design Transfer

BostonGene - Waltham, MA

Full-time

Waltham, MA

About the position

We are seeking a motivated scientist to lead our Technology and Design Transfer department. The candidate will oversee the transfer of clinical tests through the product development lifecycle, including analytical validation, assay design transfer, and process automation. The role involves optimizing workflows for clinical implementation, developing SOPs, coordinating validation processes, and ensuring compliance with CLIA, CAP, and New York State standards. This role would also involve a 10% effort on clinical report sign out, clinical QA, and communication with ordering physicians. This position is based in our Waltham, MA laboratory.

Responsibilities

• Direct the implementation and quality improvement of complex molecular testing workflows for clinical diagnostic applications.
• Establish a robust infrastructure and SOPs for deploying the BostonGene test portfolio clinically.
• Lead the transfer of R&D assays involving peripheral blood and tissue to the clinical laboratory setting.
• Manage the BostonGene laboratory test validation portfolio.
• Coordinate and execute analytical validation experiments and clinical trials.
• Supervise and coordinate specimen biobanking and external acquisition for development and validation.
• Provide technical and regulatory support for BostonGene assays and analytical approaches, to ensure smooth transitions and test execution prior to product launches.
• Work with computational biologists and bioinformaticians to meet project goals.
• Supervise junior staff to ensure timely execution of company goals.
• Collaborate with cross-departmental teams, planning risk assessments and strategy development.
• Review and sign out of clinical reports.
• Communication with clinical reporting QA and report generation teams.
• Provide expert consultation with ordering physicians when necessary.
• Work with technology domain experts to provide technical oversight and QA/QC for workflows.
• Promote innovative approaches for data and process robustness.
• Provide technical input for regulatory submissions and investigation support for deviations.

Requirements

• M.D. or Ph.D. in molecular biology, pathology, immunology or a related field.
• Board certification (ABMGG, MGP, or other relevant).
• Deep understanding of clinical diagnostic assay development and implementation.
• 5+ years' experience working in a clinical diagnostic laboratory regulated by CAP/CLIA/NYS and or FDA guidelines.
• Experience in building teams in clinical diagnostics or analytical science.
• Proven track record in developing and validating high complexity fit-for-purpose clinical assays.
• Proven ability to troubleshoot experimental protocols and train staff.
• Experience with lab start-up, analytical automation, and facility start-up.
• Strong communication and project management skills.
• Knowledge of regulations, clinical diagnostic practice, CAP/CLIA, and GCLP environments.

Nice-to-haves

• Strong leadership and team-building abilities.
• Excellent problem-solving and critical-thinking skills.
• Proficiency in data analysis and interpretation.
• Ability to manage multiple projects and prioritize tasks effectively.
• Strong organizational skills with attention to detail.
• Effective communication skills, both written and verbal.
• Ability to work collaboratively in a cross-functional team environment.
• Familiarity with bioinformatics tools and software.
• Experience in regulatory submissions and compliance.