Current Vacancies

Clinical Microbiology Study Manager.

Affinity Biosensors (Santa Barbara, CA) has opened a full-time, high-impact position to design and monitor studies that validate the performance of its LifeScale rapid antibiotic susceptibility system. 

Candidates should have extensive experience in microbiology R&D, study construction, and USFDA 510k clinical trials.  Previous experience in microbiology laboratory research or study development, and/or commercial development of in-vitro diagnostic equipment pertaining to antibiotic susceptibility testing, is highly valued.

M.S. or Ph.D. degree in Microbiology or related field is required. 

Duties include:

• Monitor ongoing clinical trials, including coordination with study monitor, communication with study sites, monitoring of study data and consumables
• Design protocols and monitor analytical studies in support of clinical trials
• Draft 510k pre-submission communications to the FDA for additional clinical trials
• Train laboratory staff on study protocols, in-house and at study sites
• Interact with engineering and quality systems groups
• Some travel required

Required Skills:

• Detailed knowledge of microbiology lab function and clinical microbiology workflow
• Superior oral and written communication skills and leadership abilities
• Ability to thrive in a n multi-tasking, multi-disciplinary environment
• Critical thinking skills for advanced problem-solving

Affinity Biosensors offers competitive salaries and benefits, and opportunities for equity.