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