The Clinical Development Scientist II is responsible for development of new technologies/platforms and assays, performance of validation studies, transfer of assays and implementation into the clinical laboratory. The Clinical Development Scientist II will perform the functions of nucleic acid isolation, quantification, testing, data analysis, recording, and reporting laboratory results as directed for specific assays/projects performed in the Clinical Laboratory under CLIA. Responsibilities also include using fundamental concepts, practices, and procedures of the particular field of specialization to perform scientific research tasks requiring application of both established and innovative techniques and procedures. In addition, the Clinical Development Scientist II will serve as technical lead on IVD project teams when appropriate.
• Provides technical oversight of the project team with support and direction from the Clinical Assay Development Manager.
• Drafts project development or validation plans and associated budget estimates and timelines.
• Independently executes experiments according to approved project development or assay validation plans, budgets and timelines.
• Critically analyzes complex data and evaluates/integrates results with project objectives;
• Identifies and solves problems in experimental designs, providing clear documentation of the problem resolution process.
• Prepares written project progress reports, project summary reports or assay validation reports as directed.
• Serves as technical lead for designated development projects, coordinating product development, performance improvement, and assay transfer collaboratively with other departments.
• Participates in fundamental literature review related to products under development;
• Performs competitive audits and product evaluations as directed;
• Participates and provides input into:
- Discussions for design and development of new laboratory technologies, platforms, and applications, following MolecularMD design control procedures as appropriate;
- Defining the specification, design, and implementation phases of new laboratory system software;
- Root-cause analyses, communicating recommendations to resolve tech problems.
- Raises regulatory/compliance concerns to the Clinical Assay Development Manager, Director of Quality & Regulatory Affairs, or Quality Control/Assurance Specialist;
- Models compliance with clinical laboratory regulatory policies, all MolecularMD policies, and contractual procedures for each MolecularMD client;
- Demonstrates strict adherence to established laboratory processes across all phases of sample handling and testing workflows;
- Demonstrates commitment to compliance with all MolecularMD Clinical Laboratory procedures, safety and regulatory work practice guidelines as defined in the Quality Management Program, the Chemical Hygiene Plan, confidentiality and HIPAA agreements, and all applicable state and federal regulations and requirements.