QC Manager at Twist Bioscience (Portland, OR)
Programmable DNA, the software of Life, is finally here! Twist Bioscience is developing a disruptive Synthetic DNA technology that will change the world, enabling widespread health and sustainability. Synthetic biologists will use our products to engineer how organisms produce cures to diseases, make everyday chemicals by using the atmosphere as the carbon source, enable plants to make their own fertilizers, and to create in-vivo diagnostics that alert us when we are sick, and many more applications.
The QC Manager will be responsible for the implementation and continuous improvement of QC methods in the production laboratory. He/she will work closely with the operations team to monitor the quality of Twist DNA products utilizing quantitative measurements, fragment analysis, NGS sequencing, etc. The successful candidate must have a demonstrated capability of making data driven decisions in a high throughput environment to assure that all products processed, packaged, stored, and distributed are manufactured in compliance with all Regulatory, Customer, and Twist requirements.
What You'll Do:
Job Duties include but are not limited to:
- Monitor QC data that is generated by the factory on a daily basis
- Ensure data is properly managed and sent through the data pipe in a timely manner
- Train manufacturing operators on SOP's for data processing and analysis
- Troubleshoot QC issues
- Establish quality and reliability standards of materials, intermediates, products and processes based on in-house capabilities and customer requirements with other members of management from Production, R&D, Marketing and Engineering teams
- Collaborate with the R&D team to transfer methods and procedures that establish and assure robust protocols for intermediates, products and processes
- Work with stakeholders to set corporate quality standards including product quality documentation, quality assurance policies, procedures protocols (SOPs)
- Setting, owning and documenting process improvement activities
- Preparation of product and process quality reports by collecting, analyzing, and summarizing information and trends
- Assuring manufacturing compliance activities meet GMP/ISO and other requirements, and all manufacturing practices and record keeping are in full compliance with the applicable regulatory agency requirements
- Preparing reports, track data and present trends and analysis
- Implementation of statistics, statistical analysis tools to build quality metrics for development and manufacturing processes
- Keen observation and attitude to proactively identify production problems/ solutions, provide solutions on lab techniques, protocols, processes, handling of product and equipment
- Build and mentor team of quality control associates
What You'll Bring:
- BS or MS in Biochemistry, Chemistry, Molecular Biology or related field
- 5+ years industrial experience in operations QC
- Supervisory or Department Lead experience managing a technical laboratory team in both processes and resources
- Knowledge of the diverse operations of chemical/biological Quality Control and Quality Assurance principles and statistics
- Knowledge of molecular biology/synthetic biology techniques such as PCR, PCA, Cloning & Sequencing
- Experience with NGS workflows and data analysis
- Willingness to be hands-on in the laboratory and learn all processes related to Synthetic Biology (Gene Synthesis) and other products
- Proven ability to troubleshoot complex problems
- Ability to use critical judgment in a very demanding environment to address product or process problems under immediate time constraints
- Ability to rapidly and effectively resolve manufacturing and/or procedural problems
- Ability to review current processes and implement productivity improvements
- Strong “people skills” to be able to deal with various personalities and levels within the organization
- Excellent verbal and written communication skills to effectively work with all levels of the organization as well as with suppliers and customers
- Excellent organizational skills and be detail oriented
About Twist Bioscience
Twist Bioscience synthesizes genes from scratch, known as “writing” DNA. Just as children learn to both read and write, the next phase of development for the genomics revolution is the ability to write DNA.
At Twist Bioscience, we work in service of people who are changing the world for the better. In fields such as health care, agriculture, industrial chemicals and data storage, our unique silicon-based DNA Synthesis Platform provides precision at a scale that is otherwise unavailable to our customers.
Twist Bioscience Corporation is an Equal Opportunity Employer. Twist Bioscience Corporation provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic characteristics, or any other category protected by law.