Sr. Scientist

Description

• Independently design and plan and execute experiments and studies.
• Performs microbiological testing to support ongoing study protocols, and testing of new instruments, AST panels, and consumables.
• Process biological specimen samples using aseptic techniques and following lab safety protocols.
• Maintain thorough records of experiments and data in lab notebook or study data sheets or designated project folders, and follow Good Documentation Practices (GDP). Maintain accurate and comprehensive records of all activities conducted in accordance with company policies and regulatory standards.
• Work independently and as a member of a cross-functional teams to support microbiology research and development activities for assigned projects
• Analyze generated data and report on it in a timely manner. Experience with large data set analysis and visualization is desired.
• Write protocols, SOPs, work instructions, and other feasibility and development documents such as plans and reports
• Prepares weekly reports and PowerPoint slides to summarize activities and accomplishments clearly and concisely. Present findings periodically at meetings.
• Provide mentorship and guidance to junior scientists and laboratory staff, fostering a culture of continuous learning and skill development.
• Investigate and assist in the troubleshooting of microbiological and system issues, deviations, and unexpected results.
• Participate in routine lab equipment and inventory maintenance as needed.
• Handle and dispose of biohazard material in compliance with OSHA and biosafety procedures and maintain a clean lab environment.
• Ensure compliance with all company policies and procedures and relevant regulations, including FDA, ISO 13485, and bioMerieux Quality and PDP procedures to ensure that all developed work products meet regulatory standards and safety requirements.
• Perform other related duties as required.

• B.S. with 5+ years relevant experience in Microbiology, Biochemistry or equivalent and/ or Medical Diagnostic development experience is desired
• OR M.S. with 3+ years relevant experience
• Minimum 3 years of laboratory bench experience preferably in a BSL2 environment, clinical microbiology laboratory experience is advantageous.
• Experience working within a fast-paced environment with strong product development background and proven proficiency in data analysis, study design, troubleshooting system issues.
• Experience in the development, verification and validation of clinical diagnostic and susceptibility assays for infectious disease desired.
• Strong organizational skills, decision making, communication, teamwork, and troubleshooting skills.
• Excellent written and verbal communication skills with the ability to present complex scientific concepts in a clear and concise manner.
• Knowledge of aseptic techniques, good documentation practices (GDP), and good laboratory practices (GLP).
• Proficiency using Microsoft Office applications (Word, Excel, PowerPoint)
• Knowledge of ISO 9001 and FDA Quality System Regulations.