Staff Process Engineer (onsite)

Company: Molecular Assemblies, Inc.
Location: San Diego
Posted on: April 1, 2025

Job Description:

Molecular Assemblies, Inc. is a private life sciences company pioneering enzymatic DNA synthesis technology to power the next generation of DNA-based products. Our patented Fully Enzymatic Synthesis (FES) technology, inspired by nature, reliably produces long, high-quality, sequence-specific DNA. This innovative approach enables advances in industrial synthetic biology, precision medicine, and emerging applications such as DNA data storage, nanomachines, and bio-based electronics. Molecular Assemblies is headquartered in San Diego, where we are transforming the future of DNA synthesis.Job SummaryThe Staff Process Engineer will play a crucial role in the development, transfer, scale-up, validation, and sustainment of production processes used to manufacture oligonucleotides using the company's proprietary synthesis technology. This role will focus on key processes involving liquid handling automation, analytical analysis, and packaging in a high throughput environment. This role will require an understanding of process development methodologies, fluidics, biochemistry, process automation, and manufacturing controls.Responsibilities:

• Participate in manufacturing process development, QC process transfer, process and product improvements, and other activities for the volume manufacturing of oligonucleotides.
• Define technical requirements for manufacturing processes and new production equipment, in partnership with R&D.
• Utilize 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 effectively 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.Don't meet every requirement? At MAI we are dedicated to building a diverse and inclusive workplace so if you don't check all the boxes in the job description, we still encourage you to apply. You may be the person we are looking for!
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Keywords: Molecular Assemblies, Inc., San Diego , Staff Process Engineer (onsite), Engineering , San Diego, California