We are seeking a seasoned Director / Sr. Director of NPI Operations who will lead and execute the transfer of R&D oligo synthesis workflows and establish pilot scale high throughput manufacturing systems for our synthetic oligonucleotide and gene products. The candidate will work as a member of an experienced R&D, Finance and Sales & Marketing management team to implement the necessary infrastructure to meet our revenue plans.  The Director / Sr. Director of NPI Operations will lead a growing team in the planning, implementation, execution, and day-to-day operation of the manufacturing, QC, packaging, and shipping of our nucleic acid products.

Duties:

  • Establish and oversee end-to-end manufacturing operations processes ensuring performance to quality, turn around time, volume, and financial goals.
  • Build a manufacturing organization for the HT synthesis of DNA oligonucleotides and genes based on Molecular Assemblies proprietary technology.
  • Coordinate with the various R&D teams in transferring oligo and gene synthesis production workflows, automation technologies, and reagent formulation procedures on-line from pilot scale operational capability to high throughput volumes according to project timelines.
  • Establish a culture of continuous improvement resulting in ongoing improvements in product quality, turn around time, and COGS.
  • Create and implement departmental SOP’s that execute the required processing tasks and meet the relevant quality system requirements.
  • Create annual and multi-year departmental headcount, expense, and capital budgets.
  • Identify, plan, and implement year-over-year growth in product manufacturing capability and year-over-year decrease in COGS.
  • Proactively identify risks to departmental success and propose action plans for resolution.

Required Experience & Skills

  • Proven track record of high volume, customized biotechnology product manufacturing; experience in synthetic oligonucleotide and/or gene synthesis highly desired
  • Experience in process transfer and scale-up from development to manufacturing environments.
  • Experience multi-stage end-to-end process driven products.
  • Experience in a highly automated processing environment and information systems desired.
  • Experience in developing high performing team and a culture of continuous improvement.
  • Excellent analytical, organizational, communications, presentation, and written skills

Qualifications:

  • BS or greater in mechanical engineering, bioengineering, physics, chemistry, molecular biology or another related field
  • 5+ years in direct manufacturing experience