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Scientist - Chemistry

Cette offre d'emploi n'est plus active.

Localisation: San Jose, CA, États-Unis
Type de Contrat: Unfixed Term
Fonction: Bioscience R&D

Description


THE COMPANY

The world is facing a medical crisis, bacteria are increasingly evolving resistance to even our strongest antibiotics. The problem is already very real and immediate; for example, bloodstream infection leading to sepsis is now responsible for more than half of all deaths in hospitals and is the most expensive condition treated in hospitals. Sepsis mortality rate increases >6% every hour without effective antibiotic treatment. Yet, despite the life and death urgency, and healthcare cost impacts, current methodologies require 3 days to determine the correct antibiotic.

Specific Diagnostics, a bioMerieux company, has developed a breakthrough solution to rapidly determine the effective antibiotic treatment for bloodstream and other acute infections. Used for bloodstream infection Specific’s solution provides results 2 days sooner (1 day vs 3 days).

We offer an opportunity to join us at an inflection point in our commercial growth, with our first commercial product being released new venture capital funding and recognition from major customers and government agencies fueling an expansion of our staff.

 

THE JOB

 

The Scientist will participate in process improvements validations for frozen panel manufacturing in an R&D laboratory setting. The scientist will provide current product support which may include manufacturing improvements, and/or QC related issues. This individual would be to perform all functions to support the production of frozen broth microdilution (BMD) panels as well as minimal inhibitory concentration (MIC) testing in accordance with cGMP, FDA, ISO and other regulations and policies at the San Jose site.

 

PRIMARY DUTIES

  1. Preparation of media, stock solutions, reagents, and buffers necessary for production of BMD panels.
  2. Assist in maintaining internal inventory for all laboratory supplies.
  3. Perform and document all manufacturing steps and verification as described in company procedures/policies including but not limited to the following:
    1. Verify that all media is appropriately labeled and stored based on all regulatory and Master Formulary specifications
    2. Proper Equipment (MDZ autospense , etc) operation and Clean-In-Place (CIP) operation
    3. Calibrations of instruments, scales and meters as needed
    4. Supporting documentation
  4. Maintain a clean and orderly work environment by following the standards set forth in department 5S guidelines - before, during and after production runs. This includes but not limited to:
    1. Cleaning and organizing lab workspace,
    2. Cleaning instrumentation/equipment,
    3. Sweeping and/or mopping floor as needed,
    4. Organizing and maintaining workstations according to 5s principles,
    5. Any unspecified actions required to maintain 5s compliance.
  5. Inspect and ensure all equipment is calibrated and in working order before performing any manufacturing task. Inform senior/principal scientist of any items found in need of repair immediately to prevent production delays. Perform start up and shut down procedures for the Lab equipment as described in company procedures/policies.
  6. Assist in the transfer of new products from research to manufacturing in a scalable form.
  7. Participate in reducing production and process related failures by providing input for building robustness in to the manufacturing process and product design.
  8. Create and present reports on conducted experiments, failure investigations and validations to upper management.
  9. Complete all defined investigations in a timely manner. Reports shall be written for all investigations and or experiments performed.
  10. This person is expected to work in a team environment to execute validations and to support and troubleshoot issues that may arise in the BMD production and MIC testing.
  11. Perform other duties and projects related to lab and department operations as requested by management.

 

 

KNOWLEDGE, EXPERIENCE & SKILLS

  1. S. with 1 year of relevant experience in Biochemistry, Chemistry, Microbiology , and/ or Medical Diagnostic is desired.
  2. Strong organizational skills, Good laboratory techniques and operation of lab equipment
  3. Good problem solving ability, Good oral and written communication skills in English
  4. Good organizational skills and computer skills
  5. A basic understanding of microbiology and analytical chemistry.
  6. Knowledge of basic chemistry and of bio-chemicals used to identify microorganisms.
  7. This individual must possess the interpersonal skills to be able to work as a Team contributor, and individual contributor. In addition, the individual shall have the ability to function in a structured/organized manner, and the ability to follow through on given tasks. 
  8. Experience in and/ or knowledge of working in a manufacturing environment. In particular, a device regulated manufacturing facility.

 

IMPACT / MANAGEMENT SCOPE

 

Decision Making –must have the ability to work unsupervised and operate with great latitude for independent judgment and initiative.

 

Decisions involving operations in the production laboratory are made daily and include:

  • The number of products and sub-components produced correctly and on schedule.
  • Ensure the team has a productive workflow to meet the customer demand.
  • Resolution of technical/material flow issues and addressing equipment malfunction.

 

WORKING CONDITIONS

 

  • Lifting (up to 75 lbs) laboratory equipment and supplies and moving containers of various materials.
  • Work involves [erforming 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.
  • May be exposed to odors incurred during media preparation and frozen panel production.
  • 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.
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