As a Scientist in the Process Development group, you will use your skills in molecular biology to interface between R&D and Operations to establish new processes or improve existing processes for NGS products. You will collaborate with the QC team to identify key control points and qualify all new methods. You will own the transfer of manufacturing processes to production groups and manufacturing process improvements. In addition to molecular biology and DNA sequencing techniques your work will include collaboration with automation engineering. You will report to the Director of Process Development and will work cross-functionally with other teams to develop, verify and validate all new processes in this lab based position.
- Collaborate with R&D to gain thorough understanding of new products and transform knowledge into production processes and methods for product production and reagent kit manufacturing under ISO 13485 compliance
- Define product specifications, processing parameters, and operational boundaries
- Independently design experimental plans, perform studies, and analyze large data sets to ensure processes and resulting products meet product specifications and regulatory requirements
- Work cross-functionally to write and execute V&V plans and evaluate results
- Write technical documents including work instructions, batch records, SOP’s and training documents for manufacturing operators
- Train manufacturing and QC operators
- Develop and maintain project timelines and provide updates and feedback to project leadership
- Learn current product production workflows and provide support/troubleshoot as needed
- Collaborate with Automation team to develop and optimize methods at scale
- Collaborate with QC team to evaluate new processes and methods at scale
- Own all aspects of tech transfer for new products including post-release QA
- Master’s degree in Biochemistry, Molecular Biology, Microbiology, Bioengineering, or related field & 3+ years industrial experience in biotechnology product development, or PhD in one of the above fields.
- Thrives in fast paced work environment
- Extremely organized and detail oriented
- Excellent written and verbal communication skills
- Proficiency with logic, statistical, and formatting functions using GoogleSheets and/or Microsoft Excel
- Motivated for both individual and team success
- Proven ability to launch products in a biotechnology or life sciences company
- Experience with automation platforms such as Hamilton/Biomek/Tecan or Echo is a plus
- Background in molecular biology techniques including PCR, DNA purification, DNA quantification, molecular cloning
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.