Under general supervision, perform directed research in developing new assays. Demonstrate proficiency in lab policies and procedures, perform experiments and analyze results.
- Perform experiments in the lab to develop tests suitable for use in a clinical lab or submission to the FDA for 510(k) clearance, depending on the specific test and the needs of the company
- Exercise discretion and judgment in planning experiments and data analysis
- Prepare reagents for use in the lab following SOPs
- Perform key procedures and experiments
- Develop and update SOPs
- Operate the Maverick instrument and troubleshoot problems that may arise
- Perform analysis of the Maverick output and recommend next steps
- Analyze data from various sources
- Document experiments in lab notebook
- Following SOPs, perform experiments that will be submitted to the FDA for 510(k)
- Demonstrate knowledge and proficiency of procedures and regulations
- Demonstrate proficiency in performing experiments and high quality output
- Communicate complex information, orally, in writing and electronically
- Communicate material of a specialized or highly technical nature
- May train others in SOPs and other lab procedures
- Work with colleagues on joint projects, as required
- Build internal contacts and participate in cross functional communication for the exchange of information and collaboration including Technology Transfer, Quality Assurance and Operations
- Maintain compliance with all company policies, quality systems and procedures
- Perform other duties as requested
- BS plus basic biochemistry, chemistry and molecular biology labs.
- A minimum of 1-2 years' experience working in a biochemistry or molecular biology lab in academia or industry.
May train other lab personnel