Clinical Development Scientist I
Overview of the role:
The Clinical Development Scientist I 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 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 Development Laboratory, potentially under the auspices of 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.
Essential duties and responsibilities:
- 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 technology 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
– Recognition and resolution of technical issues in cooperation with managers
– Root-cause analyses, communicating recommendations to resolve technical problems
- Participates in training of other laboratory staff as directed by the Managing Scientist
- Raises regulatory/compliance concerns to the Managing Scientist and/or Technical Operations Manager
- 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 Development 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.
Work Experience, Education, and Computer Skills:
- Bachelor of Science degree (B.S.), and six (6) plus years of relevant research experience; Master of Science degree (M.S.), and three (3) plus years of relevant research experience; or PhD, and relevant research experience.
- Possesses advanced specialized computer skills that require mastery of applicable software in such fields as technical writing, statistics and web-based training.
If you are interested in joining our team and would like to be considered for a future job opening, please email your resume to: email@example.com