This is an exciting opportunity for a bioanalytical scientist to join our staff at our San Jose facility and work on novel projects involving drug-device combinations for treating chronic diseases with the potential to dramatically change patient outcomes.   Position, salary and benefits are commensurate with experience.  All full time salaried employees are offered an attractive compensation package which includes medical insurance benefits, relocation, 401K, and paid vacation. In addition, all full time salaried employees receive option grants. 

The ideal candidate is expected to play a pivotal role in our R & D team. The candidate must have a background in medical device or pharmaceutical testing and regulatory development. Experience in preclinical and clinical research is a must. The candidate must have a background in biochemical analysis such as spectrophotometric, fluorescence immuno assays, HPLC, CE, LC-MS. Experience with microplate assays is must and experience with Luminex MapX technology is an advantage.

• Perform bioanalytical assays for the quantification of the analytes in in vitro, preclinical and clinical samples. 
• Participate in the development of in vitro/in vivo models by performing a variety of microplate assays independently with minimal supervision. 
• Configure, program and troubleshoot laboratory automated platforms.
• Optimize existing automated processes to improve efficiency, throughput, robustness and quality.
• Understands the principles, concepts and methodology governing the work performed 
• Fully understands the rationale and hypotheses for experimental designs 
• Demonstrates solid technical skills and working familiarity with laboratory procedures and processes 
• Reads and understands scientific literature directly related to his/her experiments, as assigned 
• Performs literature searches independently and begins to interpret results 
• Begins to acquire an understanding of the scientific implications of scientific literature for his/her projects/functions 
• Performs routine data management tasks including recording results effectively in a laboratory notebook or computer independently (i.e., tabulating and graphing results) 
• Support regulatory efforts through understanding of relevant standards and interpretation of FDA Guidance documents.
• Actively participate in company-wide research meetings, including making detailed scientific presentations. 
• Work cooperatively with scientists, personnel in other departments. 
• Other duties as assigned.

Teamwork 

• Participates effectively as a member of a team within his/her laboratory/project 
• Proactively seeks assistance, when necessary, from other scientists to solve problems with procedural protocols 
• Promotes exchange of ideas and information

Laboratory Management Responsibilities 

• Maintains cleanliness in his/her own work area and in communal work areas 
• Responsibly ensures adequate maintenance of laboratory supplies and equipment

Safety 

• Responsible for his/her own safety in the laboratory, and alertness for the safety of co-workers and visitors 
• Learns safety requirements for his/her laboratory. Attends safety training, as appropriately needed 

Education and/or Job Experience

• Minimum work experience: a Bachelor’s degree with 2-5 years of work experience or a Master’s degree plus 0-3 years of work experience (academia- or industry-based) or a Ph. D. with at least 2 years of industry experience 
• Executes experiments based on established protocols and implements improvements with limited supervision 
• Hands-on experience in automation and liquid handling in a bioanalytical lab setting
• Knowledge and experience of working with statistical software like Excel, GraphPad Prism and Softmax Pro.
• Experience with writing reports/protocols and SOPs.
• Excellent oral and written communication skills