Scientist Assay Development

San Diego, CA Operations - Process Development Full Time
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Element Biosciences is a multi-disciplinary startup focused on innovating genetic analysis tools for the research and clinical markets. The Company's technology will broaden the end user experience through improved data quality and simplified workflows to benefit discoveries and diagnosis in healthcare. We are seeking a highly motivated scientist to develop assays and processes for our Biochemistry & Chemistry Process Development teams. This position is integrated with our technology and product development teams, with a focus on pulling the technology out of the lab and enabling it in operations. The scientist will be responsible for assay development and product transfer activities, and will play an important role in vendor qualifications, specification development, stability studies, QC and production documentation (e.g. SOP, WI), and QC training/transfer. The is a highly cross-functional role across multiple departments and technical disciplines, and the successful candidate must have demonstrated success working in a fast-paced environment with varied responsibilities and rapidly changing priorities.    The scientist will have strong analytical skills in chemistry and biochemistry, experience in the reagent life sciences field, and experience utilizing various project management tools, design tools, and statistical analysis tools to ensure the delivery of robust, reliable, and accurate processes to routine manufacturing.

Responsibilities:

  • Develop well characterized, robust, and reliable QC assays and processes to QC and manufacturing teams
  • Establish relationship between product requirements, product performance, and manufacturing capabilities to determine meaningful QC specifications
  • Support product commercialization at interface of R&D and QC/Manufacturing
  • Design, plan, and execute experiments, complete data analysis, present results and make recommendations based on data
  • Source and qualify external vendors
  • Identify opportunities for process improvements
  • Author QC and production documents
  • Train QC and manufacturing personnel

Requirements:

  • A Master’s Degree in Chemistry, Biochemistry, or a related scientific discipline or equivalent field of study with 2+ years of experience in a relevant industry such as life sciences, medical devices, diagnostics, biotechnology, pharmaceutical, or related scientific field (an equivalent combination of experience and education may be considered)
  • Experience in HPLC instrumentation and method development
  • Expertise in biochemistry, chemical biology, and/or molecular biology
  • Hands on experience in the laboratory in assay and product development
  • Effective verbal and written communication skills and proven experience interfacing between R&D and Operations teams
  • Skilled in experimental design and statistical data analysis/visualization (e.g. JMP)
  • Proven ability to structure manufacturing processes such as BOMs
  • Strong collaborative and teamwork attributes
  • Ability to take initiative, multi-task, and independently drive projects to completion with detailed and efficient execution and reporting
  • Experience with NGS technology is desired
  • Knowledge of business process systems is a plus
We are passionate about our mission to develop high performing products to study genomics in an unprecedented flexibility and to understand biology for the improvement of healthcare. We have built a highly efficient product-driven organization where employees can learn, grow and thrive in a challenging but encouraging environment.  We are committed to scientific integrity, collegiality, honesty, objectivity, and openness.   We offer excellent benefits, which include a 401K plan, competitive health benefits, flexible vacation, and equity incentives.  We foster an environment such that all people are afforded the freedom to pursue their passions without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.