Sr. Scientist

Company: bioM--rieux SA
Location: San Jose
Posted on: September 16, 2023

Job Description:

Specific Diagnostics, a BioM--rieux company, is a medical device company that has developed a rapid antimicrobial susceptibility test (AST) system that delivers phenotypic AST directly from positive blood cultures. Our mission is to provide innovative and reliable medical devices that improve patient outcomes and enhance the life of people around the world. Our team of highly skilled professionals is dedicated to excellence in research, development and manufacturing and we are looking for a Sr. Scientist to join our Microbiology department. Job Overview The Sr. Scientist will be responsible for performing and documenting experiments that are part of the internal analytical studies and product stability studies. You will be responsible for authoring documents, following protocols, analyzing, and presenting results. They will work in cross-functional teams to ensure that the studies performed meet all necessary regulatory and quality standards for invitro diagnostic (IVD) products. Candidates with a strong microbiology background, susceptibility testing and product development experience in a regulated environment are strongly encouraged to apply. PRIMARY DUTIES

• Participate in projects relating to product stability and analytical studies.
• Following protocols and SOPs pertaining to 510K FDA applications.
• Daily data monitoring and weekly data analysis.
• Coordinating with other teams and departments
• Create and present reports on conducted experiments, failure investigations and validations to upper management. -
• Participation in regular lab operations included running experiments, maintenance, and routine tests.
• Perform other duties and projects related to lab and department operations as requested by management. KNOWLEDGE, EXPERIENCE & SKILLS
  • S. with 3+ years relevant experience or Master 1+ years in Microbiology, and/ or Medical Diagnostic is desired.
  • 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 and validation of clinical diagnostic and susceptibility assays for infectious disease.
  • Strong organizational skills, decision making, communication, teamwork, and troubleshooting skills.
  • Must be able to work both independently with minimal guidance or oversight as well as in tandem with all levels of corporate personnel. Show understanding, tact, and patience when working with diverse team members to maintain positive working relationships throughout the company.
  • Make sound, well-informed judgments with the quality of product at the top of their mind when forming decisions. Lead by example and reinforcing corporate values that lead to the department's success.
  • Clinical microbiology laboratory experience is a plus.
  • Knowledge of ISO 13488 and FDA Quality System Regulations is desired. WORKING CONDITIONS
    • Domestic travel requires 10 % of time.
    • International travel required 5 % of time.
    • Lifting (up to 25 lbs) laboratory equipment and supplies and moving containers of various materials.
    • Work involves performing computer applications and standing for extended periods of time.
    • Operating within cool temperature and low humidity conditions within the production room.
    • Constant noise is common due to the operation of the air-dry chamber, taping and pouching equipment. -
    • May be exposed to and require the handling of antibiotics and other hazardous materials.
    • Lab work is performed wearing safety glasses and lab coat. Excellent personal hygiene required. -
    • Reasonable, reliable attendance and punctuality is an essential job function required for this position. BENEFITS The estimated salary range for this role based in California is between $ 84,100 and $ 100,900 annually. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux's bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate's experience and will be presented in writing at the time of the offer.
      • A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
      • Company-Provided Life and Accidental Death Insurance
      • Short and Long-Term Disability Insurance
      • Retirement Plan including a generous non-discretionary employer contribution and employer match.

Keywords: bioM--rieux SA, San Jose , Sr. Scientist, Other , San Jose, California