Company: bioM--rieux SA
Location: San Jose
Posted on: November 17, 2023
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
- Following protocols and SOPs pertaining to 510K FDA
- 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 &
- 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
- 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
- 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
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