Performs and directs assays according to and in compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs).
Sufficiently competent in science to initiate and carry out scientific development projects related to the development of new assays, initiation of new programs, assay validations and associated projects. Schedules and directs assays under the supervision of the Study Director. Assists with training junior staff members. Performs Research & Development activities and acts as Study Director as required.
Assists supervisor with day-to-day lab management duties. Correctly analyzes scientific data with accuracy and precision.
- Performs DNA sequencing assays and other PCR-related tests with a high degree of independence.
- Able to train junior level staff on DNA sequencing assays.
- Performs Study Director functions for sequencing assays.
- Designs and performs assay development work for PCR-based sequencing tests.
- Demonstrates scientific technical expertise. Ability to troubleshoot problems.
- Effectively communicates and defends science through written and verbal communication.
- Presents technical seminars and provides training on areas of technical expertise and compliance issues relevant to the lab setting.
- Reviews and signs lab notebooks
- Conducts and directs assays and lab procedures according to and in compliance with GLP, cGMP, CFR, and/or PTC guidelines and SOPs.
- Accurately completes batch records and other required documentation according to and in compliance with GLP, cGMP, CFR and/or PTC guidelines and SOPs.
- Contributes independently to overall scientific rigor through objective laboratory investigation.
- Demonstrates proficiency in scientific theory and rigorous practical application in the completion of lab procedures.
- Conducts critical review of results and reports data to Study Director or supervisor.
- As assigned by Management, acts as Study Director for specific assays and assumes all associated responsibilities.
- Independently initiates and carries out scientific development projects relating to the development of new assays.
- Trains new personnel in lab procedures.
- Effectively interacts with clients as required.
- Schedules lab work.
- Performs Research & Development activities as required.
- Maintains laboratory notebook and follows all general and laboratory SOPs.
- Performs assays using appropriate laboratory techniques for lab group assigned to.
- Communicates with supervisor and other colleagues re: daily lab activities.