Associate Director of Operations, CRISPRevolution
Redwood City, CA, USA
Posted on Friday, August 18, 2023
Synthego is enabling genome engineering at scale with a blend of scientific instrumentation, industrial automation, and data science. Our team of scientists and engineers are putting multidisciplinary fields together to solve problems that no one field can tackle alone.
We are searching for an experienced and innovative leader to manage our CRISPRevolution operations. With a focus on quality and scale, this role will be responsible for establishing world-class operating protocols. The ideal candidate is well-versed in lean manufacturing, visual management, and has experience working with high-throughput, made to order reagent operations. This position requires the tact to mentor and develop others, as well as the sense of urgency and ability to get hands-on when necessary.
What You'll Do:
- Develop and implement the overall operational strategy for manufacturing, aligned with the company's goals, objectives, and market demands.
- Hire, manage, mentor, and develop a growing team of chemists, operations managers/supervisors, and process engineers responsible for the manufacture and scale up of synthetic products for CRISPR applications
- Drive the development of streamlined order intake processes, order management/LIMS systems, and innovative customer communication protocols
- Prepare regular reports on production performance, key performance indicators (KPIs), and operational metrics, and use data-driven insights to make informed decisions.
- Formulate and implement supply chain strategies designed to improve cost and quality, free cash flow, and operational uptime
- Collaborate with science, engineering, and marketing teams to design and implement innovative solutions to meet and exceed customer expectations across the CRISPRevolution product portfolio
- Design and implement standardized laboratory management and maintenance protocols leveraging lean manufacturing methodologies
- Coordinate with systems engineering and quality to ensure the seamless transfer of new products and processes into production
- Implement robust quality programs, on-boarding processes, and employee development programs to support reproducible, high quality scale up initiatives while building out high-performance teams. Ensure sustained compliance to training program
- Uphold strict production and quality control processes to ensure incoming, in-process, and finished goods materials meet specifications
- Oversee investigations related to deviations, non-conformances and customer complaints; review and approve CAPAs and Change Orders related to the manufacture of CRISPR products
- Identify potential risks in the manufacturing process and develop mitigation strategies to ensure the consistent delivery of products.
- Maintain Good Manufacturing Practices; monitor manufacturing environment and facility to ensure compliance
- Participate in internal and external audits representing Operations; ensure corrective actions are implemented for any findings
- Ensure lab standards are upheld, labware and equipment are properly maintained, and hazardous materials are disposed of in accordance with regulatory requirements
- B.S. and 5+ years experience managing a production laboratory operation
- Strong understanding of process control, high throughput manufacturing, and technology transfer processes
- Strong understanding of laboratory best practices, continuous improvement methodologies, and lean manufacturing principles, including 5S, Gemba, and Kaizen
- Experience in Oligonucleotide manufacturing production process and associated technologies, strongly preferred
- Ability to adapt to changing business needs and market dynamics.
- Experience with Pharmaceutical (GMP) Good Manufacturing Practices ICH Q7, preferred
- Experience with formal quality management systems required; ISO 9001:2015, ICH Q10, preferred
- Innovative, motivated, and independent leader possessing a player/coach mentality
- Financial acumen and budget management skills.
- Excellent communication and interpersonal skills
Company Perks & Benefits
- Generous equity
- Medical, dental, and vision benefits
- 401k Program
- Subsidized catered lunches and dinners with a fully stocked kitchen & snacks
- Onsite Gym
- Daily Shuttle bus to & from San Francisco
- Paid parental leave
- Flexible paid time off
- Learning and Development resources
Synthego is a genome engineering company that enables the acceleration of life science research and development in the pursuit of improved human health.
The company leverages machine learning, automation, and gene editing to build platforms for science at scale. With its foundations in engineering disciplines, the company’s platforms vertically integrate proprietary hardware, software, bioinformatics, chemistries, and molecular biology to advance basic research, target validation, and clinical trials.
By providing both commercial and academic researchers and therapeutic developers with unprecedented access to cutting-edge genome engineering, Synthego is at the forefront of innovation, accelerating the development of truly engineered biology.