Associate Principal Engineer, Protein Process Development

San Diego, California, United States Process Engineering 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 looking for a driven, passionate professional to co-develop our processes with our products.  We look for flexible candidates eager to build an amazing company and launch an amazing product!  The Process Development team 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.

This role will be working on developing the enzyme consumable component of our product.  Our product incorporates cutting edge technology from synthetic organic, nucleotide, enzyme, and surface chemistry disciplines, which makes this role highly integrative. The ability to provide leadership across multiple organizations and sites is important.

Essential Functions and Responsibilities

  • Lead projects in the enzyme area to support the transfer and commercialization of the product/process, including design and implementation of processes, QC’s, and methods to enable a robust manufacturing line
  • Design, plan, and execute product and process characterization experiments and stability studies
  • Lead the design of experiments, driving execution, data analysis, and presentation of outcomes, making recommendations based on data
  • Scale up from mg to grams for manufacturing process development, validation, and production
  • Work with production to build documentation for user and system requirements
  • Lead complex investigations, troubleshooting sequencing product performance issues
  • Mentorship of more junior engineers/scientists
  • Potential to manage a team
  • Other duties as assigned

Education and Experience

  • BS/MS/PhD. in Chemical, Biochemical and Bioengineering or Molecular biology, Biochemistry and Protein chemistry (an equivalent combination of experience and education may be considered)
  • At least 12 years of academic or industry experience developing, validating, and implementing recombinant protein production workflows.
  • Experience in both Development (new product introduction) and Operations settings, preferably with experience commercializing products in a fast-paced Biologics, Molecular Biology, or Chemistry environment
  • Experience in pilot/full-production environments, including tech transfer activities, sustaining support, and continuous improvement 
  • Hands on experience with AKTA instrumentation
  • Strong working experience with various research-scale affinity methods and producing grams scale for protein purification and production
  • Experience in protein characterization (HPLC SEC/RP, qPCR, Kinetic Assay and SeqStudio Genetic Analyzer system) is preferred
  • Experience with manufacturing infrastructure setup such as WI, SOP, BOM and MBR

Required Skills/Abilities

  • Independently design and execute protocols
  • Familiarity with various modes of chromatography (IEX, HIC, RPC, SEC, affinity)
  • Creative and independent thinker
  • Excellent communication skills
  • Good team worker
  • Ability to multitask and work independently
  • Ability to find creative solutions to problems

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.

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