Director, R&D

Scientific/R&D San Jose, California


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Description

The estimated salary range for this role based in California is between $132,358 and $216,700 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.  

In addition, bioMérieux offers a competitive Total Rewards package that may include: 

·         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. 

·         Adoption Assistance 

·         Wellness Programs 

·         Employee Assistance Program 

·         Commuter Benefits 

·         Various voluntary benefit offerings 

·         Discount programs 

·         Parental leaves 

Specific Diagnostics, a BioMérieux 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.  

We are seeking a highly motivated and experienced Director to join our innovative In Vitro Diagnostic (IVD) company. This leadership role in our Microbiology Department will focus on guiding and supporting the development of cutting-edge Antibacterial Susceptibility Testing (AST) assays. The ideal candidate will have a deep understanding of microbiology and AST, coupled with strong leadership and technical skills to contribute to the growth and success of our company. The ideal candidate will have a deep understanding of microbiology and AST, coupled with strong leadership and technical skills to contribute to the growth and success of our company. They will lead a team of scientists and contribute to the development of AST assays on the VITEK REVEAL platform. Strong technical acumen, communication and collaboration skills are essential, as this position interacts closely with many teams across the organization. 

Primary Duties:  

    • Lead and provide day-to-day scientific, managerial, and organizational structure to a team of scientists and researchers involved in the development of AST assays and microbiology research/testing.
    • Provide technical expertise in microbiology, antimicrobial susceptibility, and assay development to drive solutions and high-quality test development.
    • Oversee and contribute to the planning, execution, and documentation of assay development projects.
    • Collaborate with senior management to develop a strategic roadmap for AST projects.
    • Set team goals and timelines to align with the company's overall objectives.
    • Ensure that all AST assays developed adhere to relevant regulatory requirements (e.g., FDA, ISO13486 and EU IVDR) and industry standards.
    • Recruit, mentor, and develop a team of skilled scientists, fostering a culture of innovation, accountability, and continuous improvement.
    • Provide mentorship, direction, and support to team members to achieve their full potential.
    • Foster cross-functional collaboration by working closely with R&D teams, Quality Assurance, Marketing, and other relevant departments.
    • Communicate project progress, challenges, and results effectively to various stakeholders.
    • Contribute to the writing of technical documents, Project related documents, SOPs,  WI etc.. and prepare presentation materials for communication in iternally and externally as needed
    • Manage a team of 5

Qualifications:  

  • Ph.D. in Microbiology, Molecular Biology, or a related field.
  • A minimum of 10 years of  experience with 8 in medical diagnostic product development, and minimum of 6 years managing scientific teams ranging from junior scientists to managers or principal scientists.

Additional Qualifications Needed:  

  • Experience in microbiology research and assay development, with a strong focus on antibacterial susceptibility testing desirable.
  • Proven leadership experience in managing teams in a laboratory setting.
  • Ability to efficiently manage technical goals and business objectives in parallel
  • Working knowledge of IVD regulatory requirements and quality standards.
  • 820.30 Design Controls and knowledge of, or previous experience of, developing products under design control as well as risk management standards
  • Excellent project management skills and the ability to handle multiple projects simultaneously and drive to results with high emphasis on quality.
  • Strong written and verbal communication skills and influential skills
  • A collaborative, proactive, and innovative mindset.
  • Self-motivated, HIGHLY organized, and flexible.
  • Full English fluency required.

BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. 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 BioFire Diagnostics’ 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).