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Microbiology R&D Director/Sr Director

Location: San Jose, CA, United States
Position Type: Unfixed Term
Job Function: Bioscience R&D

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.

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 Microbiology Director provides medical and scientific expertise to support the product life cycle in collaboration with various cross-functional teams within Specific Dx. This position reports to the Vice President of R&D. The job includes experimental research and development and team management to support in vitro diagnostic systems. Experience in product development for medical diagnostics is required. Ideally, you have proven expertise in planning and executing laboratory experiments, directing a team of microbiologists, prioritizing and planning scientific projects and collaborating with cross-functional teams. You have experience working within regulatory guidelines. Domain knowledge in protocols and the execution of clinical studies is a plus. This is a senior role; you will be a key contributor and critical to the success of the company.

You must be able to work in compliance with FDA and ISO guidelines in the regulated IVD arena. Key responsibilities include:

  • Working independently and as a member of a cross-functional team to support microbiology research and development.
  • Assuring the successful planning and completion of studies resulting in timely presentations.
  • Managing the team of Scientists responsible for leading or supervising the analytical and clinical studies.
  • Providing team members with technical guidance as well as identifying resources needed to meet or exceed project goals.
  • Authoring and reviewing protocols, reports, SOPs, work instructions, and other product-related documents. Create and edit the medical and scientific content of documents and presentations.
  • In-depth knowledge and proficiency in standard microbiological methods.
  • Managing the budget and resource prioritization, allocation, and realization.
  • Participate in health hazard and risk assessments as requested.
  • Assure quality reporting and communication within Microbiology and with external teams.

Job Type:

  • Full-time

Education:

  • PhD. (Preferred)

Experience:

  • Microbiology: 8 years (Preferred)
  • Laboratory Experience: 5 years (Required)
  • Leadership Experience: 4 years (Preferred)

Work Location:

  • On site

Work Remotely:

  • No

Travel: 

  • 15-20%

 

You

Self-motivated, highly organized, and flexible. Ability to independently manage multiple projects and rapidly adapt to shifting priorities.

Characteristics and skills:

  • Proven proficiency in research design, troubleshooting, and evaluation of new technologies and procedures.
  • Leadership experience. Experience, training, and talent to manage a team of microbiologists. Previous track record of project management within a fast-paced environment a plus.
  • Experience in the development and validation of clinical diagnostic/susceptibility assays for infectious disease.
  • Experience working with multidrug-resistant bacteria.
  • Evidence of scholarly achievement with a strong research background and peer-reviewed publications. Good presentation skills.

 

Education and Experience:

 

  • Advanced degree (Ph.D.). Completion of a fellowship in microbiology.
  • At least 4 years of technical and people management experience working in a microbiology laboratory or similar position in the industry in the areas of infectious diseases, microbiology, and clinical research.
  • Comprehensive knowledge of antimicrobial susceptibility testing, pathogen identification, and blood culture management.
  • Experience in clinical study design, execution, monitoring, and completion.
  • Understanding of microbiology test methods, global regulatory standards (CLIA, FDA), and clinical practice guidelines (CLSI, EUCAST).
  • Excellent interpersonal, analytical, communication (oral and written), presentation, and project management skills.
  • Strong prioritization and decision-making skills.
  • Team player, flexible, adaptable, growth mindset.


Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at [email protected].

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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