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 Senior Scientist is responsible for leading process improvements calidation for frozen panel manufacturing in an R&D laboratory setting. The individual shall also be a subject matter expert that will provide support of current and new products in regards to manufacturing, QC related issues, and microbiology research and development. This position will also be expected to troubleshoot issues and perform root cause analysis for issues that arise during the frozen broth microdilution (BMD) panel manufacturing process and minimal inhibitory concentration (MIC) testing setup at the San Jose site.
- Manage the transfer of new products from research to manufacturing in a scaleable form.
- Provide technical expertise to projects related to scaling-up and/or automating production processes in order to meet demands.
- Provide expert knowledge of departmental procedures and consistently uphold all company policies. Ensure all procedures reflect the current methods used by the team. Develop and write new procedures as needed. Assist in coordination of training on technical updates and procedural revisions.
- Manage projects related to investigating failures in current product production or testing processes. Validate corrective actions and monitor the implementation of preventive actions and process improvements resulting from these failure investigations.
- Participate in manufacturing verification activities for new development rounds. This will include involvement with Design documentation, attending development meetings, determining CQA/CPP for manufacturing processes, and developing testing plans and protocols to determine manufacturability of all newly developed products.
- Perform and document all manufacturing steps and verification as described in company procedures/policies for the following, but not limited to:
- Verify that all media is appropriately labeled and stored based on all regulatory and Master Formulary specifications
- Proper Equipment (MDZ autospense, etc) operation and Clean-In-Place (CIP) operation
- Calibrations of instruments, scales and meters as needed
- Train new and coach existing team members to develop strong technical and leadership skills throughout the department. Track progress of on-the-job training of new employees.
- Troubleshoot instrument and/or equipment repair immediately to prevent production delays and get in touch with field service engineers from the manufacturer when appropriate. Identify areas of deficiency and implement best practices to improve employee safety and reduce cost incurred by poor process design.
- Create and present reports on conducted experiments, failure investigations and validations to upper management.
- Participate in reducing production and process related failures by providing input for building robustness in to the manufacturing process and product design.
- Perform Risk Analysis for validations when required and to qualify secondary vendors in or to reduce production and vendor-related risks. This task involves understanding the manufacturing environment and the details associated with implementing process/cost improvements.
- Support the standard of cleanliness set forth in department 5S guidelines by administering frequent internal audits. The audits checking for but not limited to:
- Clean and organized lab workspaces,
- Clean instrumentation and equipment,
- Workstations maintained according to 5s principles,
- Any unspecified actions are undertaken that are required to maintain 5s compliance.
- This individual will be responsible for interacting with other departments within the San Jose site.
- Perfom other duties and projects related to lab and department operations as requested by management.
KNOWLEDGE, EXPERIENCE & SKILLS
- S. with 5+ years relevant experience or M.S. with 4+ years relevant experience in Biochemistry, Chemistry, Microbiology , and/ or Medical Diagnostic is desired
- Experience working within a fast-paced environment with strong research background and proven profiecientcy in data analysis, research design, troubleshooting and evaluation of new technologies and procedures.
- Experience in the development and validation of clinical diagnostic and susceptibility assays for infectious disease.
- Familiarity with a GMP production environment, procedures and
- 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 success of the department.
- Clinical microbiology laboratory experience is a plus.
- Knowledge of ISO 9001 and FDA Quality System Regulations is a plus.
- LEAN manufacturing experience is a plus.
- Six Sigma process knowledge and working experience of GMP, GLP and GDP’s is a plus
- Knowledge and work experience dealing with regulatory agency (e.g., FDA and ISO) requirements is a plus.
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
- Management and scheduling of break times
- Resolution of technical/material flow issues and addressing equipment malfunction
- Timing of new technician training certification
- 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.