San Mateo Metro Area, CA
Develops methods, designs, plans, performs and interprets scientific experiments for the advanced analytical analysis of starting materials, in-process materials, and finished materials. Perform material analysis by utilizing chromatographic method development and execution.
Accountabilities Independently designs multiple studies or develops non-standard procedures of higher complexity which requires studying multiple variables and critical attributes to achieve functional deliverables. Upon completion, work is reviewed for adequacy in meeting objectives. Provides technical leadership by troubleshooting problems of moderate complexity and developing thorough, practical solutions that are consistent with organization objectives and require creativity. Has general knowledge of most typical functional activities and deep knowledge in 1-2 specific areas. Executes studies and conducts testing without deviation. Analyzes data from multiple, complex studies to derive a decision on functional deliverable. Thoroughly and clearly documents experiments in laboratory notebook, prepares technical documents for single, multiple, standard, complex studies. Writes sections of regulatory documents related to function deliverables. Communicates and collaborates with colleagues within the function and within sub-teams. Communicates functionally with supervisor and mentor. Participates constructively in functional -teams and at lab meetings. Offers assistance to co-workers. May lead a functional sub-team to achieve specific functional.
Preferred experience and troubleshooting abilities with chromatographic techniques such as gas chromatography (GC) and with high performance liquid chromatography (HPLC or UPLC), in additional to other standard analytical chemistry analyses. Experience with medical device analytical chemistry testing according to ICH and ISO guidelines.
Key Performance Indicators
Quality No critical audit observations. Quality Formal CAPAs and deviations not more than 30 days past due. Adherence to standards, in particular, quality, ethical, health, safety, and environment (HSE), and information security (ISEC) standards. Measurable contributions to increasing efficiency and productivity in the work related to assigned projects. Adherence to costs, quality, quantity, and timelines for all assigned tasks. All studies conducted are thorough, technically sound, completed in a timely manner and will meet regulatory guidelines.
Minimum 2 years for MS or 1 year for Ph.D (or equivalent) of directly related scientific experience
Preferred: Advanced Degree in a scientific or relevant discipline (Ph.D or equivalent)