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.