Staff Process Engineer

3 days ago

San Diego, California, United States Molecular Assemblies, Inc. Full time
About Us

Molecular Assemblies, Inc. is a pioneering life sciences company that is revolutionizing the field of DNA synthesis technology. Our innovative approach to enzymatic DNA synthesis has enabled us to produce high-quality, sequence-specific DNA with unprecedented efficiency and accuracy.

Job Summary

The Staff Process Engineer will play a critical role in the development, transfer, and scale-up of production processes used to manufacture oligonucleotides using our proprietary synthesis technology. This role will require a deep understanding of process development methodologies, fluidics, biochemistry, process automation, and manufacturing controls.

Responsibilities:
  • Participate in the development of manufacturing processes, quality control process transfer, and process improvements for the volume manufacturing of oligonucleotides.
  • Define technical requirements for manufacturing processes and new production equipment in partnership with R&D.
  • Utilize a deep understanding of critical-to-function parameters to develop process and quality controls.
  • Act as the voice of operations on cross-functional teams to ensure effective transfer of products and processes to manufacturing.
  • Collaborate with R&D, Finance, Quality, Supply Chain, and other functions to translate requirements into manufacturing.
  • Author procedures and instructions for new manufacturing processes and train production operators to manufacture product.
  • Source production equipment and materials from vendors to enable volume manufacturing.
  • Lead process/equipment validations, CAPAs, complaint investigations, product and process non-conformances, risk management, and supplier surveillance.
  • Utilize experience in structured problem-solving approaches to troubleshoot product and process issues.
Experience & Skills:
  • Experience integrating complex biochemical and fluidic processes onto liquid handling automation in a production environment.
  • Experience with assembly and packaging automation.
  • Experience implementing automated workflows and data pipelines in partnership with software/informatics teams.
  • Experience scaling up manufacturing processes from prototype through high-volume production in a rapid innovation environment.
  • Experience with methodologies such as FMEA, SPC, Gauge R&R, DOE, and structured problem-solving approaches (6-sigma, DFSS, 8D, etc.).
  • Demonstrated ability to accomplish goals while working cross-functionally.
  • Strong communication skills and ability to work effectively across functions and disciplines.
  • Experience leading projects in a dynamic environment while balancing priorities, resourcing, and deliverables accordingly.
  • Demonstrated ability to balance innovation with the need to maintain manufacturing rigor.
  • Experience with techniques including sequencing, HPLC, and mass spectroscopy is a plus.
  • Experience with protein and nucleic acid biochemistry is a plus.
  • Experience with regulated production (e.g. CLIA, GMP) is a plus.
Qualifications:
  • B.S. or M.S. in Engineering - Bioengineering, Chemical, Mechanical, Electrical, Industrial, Controls - or similar discipline.
  • 10+ years of industry experience with development of new production processes and new production transfer.
Health & Benefits at MAI:
  • Salary Range: $120,000 - $150,000. The base salary range represents the low and high end of the anticipated salary range for this position. The actual base salary offered for this position will be based on many factors including but not limited to individual performance, location of job, experience, and skills required for this role.
  • Medical, dental & vision plans offered.
  • 401k plan.
  • Generous stock options.
  • Paid vacation days.
  • Bonus eligible role.

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