Scientist I – QC Development

Molecular Assemblies is a San Diego-based company pioneering an enzymatic DNA synthesis technology towards more accurate and longer synthesis product compared to traditional chemical synthesis. This technology is capable of powering new products in industrial synthetic biology, personalized therapeutics, precision diagnostics, and eventually information storage, nanotechnology and more.

This candidate will be a crucial contributor to the team by defining our QC workflows as part of the biochemistry development team, helping define and ensure our reagent formulation processes meet requirements and specifications.

RESPONSIBILITIES:

  • Define Quality Control (QC) workflows with the goal of ensuring raw and in-process materials to meet requirements for enzymatic DNA synthesis.
  • Perform tasks related to QC functional responsibilities such as, quality requirements, stability, validations, inventory maintenance, and continuous improvement efforts.
  • Perform test and inspection procedures in compliance with written and approved standard operating procedures (SOP).
  • Create (SOP) related to analytical and functional methods or other laboratory operations such as sample management, stability programs, product release or storage controls.
  • Create Certificates of Testing, Certificates of Analysis and other applicable lot release documentation as needed.
  • Create and own medium to high-risk Non-Conformances/Deviations/CAPAs.
  • Lead and participate in cross-functional teams.
  • Documentation of experimental results in ELN; preparation and presentation of experimental results, reports and project plans to R&D colleagues and company management.

REQUIRED EXPERIENCE & SKILLS:

  • Minimum of 3 years hands-on experience in a manufacturing or R&D laboratory or equivalent.
  • Strong analytical chemistry and biochemistry skill set.
  • Direct experience in QC and reagent development is a plus.
  • Basic knowledge of enzyme activity and kinetics is required.
  • Experience with independent experimental design and execution, data analysis, and troubleshooting.
  • Experience with liquid handling robots a plus.
  • Strong work ethic and team player.
  • High attention to detail, highly organized and strong documentation skills.

EDUCATIONAL LEVEL, EDUCATIONAL DISCIPLINES:

  • Minimum B.S. (with 7+ years), M.S. (with 5+ years) or Ph.D. (with 1+ years) research/industry experience in lab environments, respectively, with degrees in Life Sciences (Molecular Biology, Biology, Chemistry, Biochemistry, Biotechnology) disciplines.