Staff Engineer: Enzyme Process Development

San Diego - Headquarters 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 work across multiple organizations and sites is important.

Responsibilities:

  • Lead and support projects in the enzyme area to enable the transfer and commercialization of the product/process, including design and implementation of processes, QC’s, and purification 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 purification process development, validation, and production.
  • Build manufacturing documentation for user and system requirements.
  • Lead complex investigations, troubleshooting product performance issues.
  • Other duties as assigned.

Skills:

  • Experience in pilot/full-production environments, including tech transfer activities, sustaining support, and continuous improvement is required.
  • Experience with bioanalytical protein methods and biochemical assay of polymerases and other DNA interacting enzymes.
  • Hands on experience with AKTA instrumentation is required.
  • Strong working experience with various research-scale affinity methods and producing grams scale for protein purification and production.
  • Independently designing and executing protocols.
  • Familiarity with various modes of chromatography (IEX, HIC, RPC, SEC, affinity) is a must.
  • 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.
  • Creative and independent thinker; excellent communication skills; good team worker; ability to multitask and work independently; and ability to find creative solutions to problems are required.

Desired experience in the following technical areas:

  • Next-generation sequencing
  • Molecular biology
  • Reagent development
  • Enzyme and recombinant protein manufacturing

Experience and Education:

  • 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 6 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.

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.