As a Sr. Research Associate in the Process Development group, you will use your skills in molecular biology to support the development of regulated NGS products for diagnostic use. Your work will include collaboration with R&D, manufacturing, and QC teams and own the transfer of manufacturing and QC processes. You will report to the Director, 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.
- Maintain compliance with regulatory requirements (e.g. FDA, EU MDA, ISO)
- 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 stability test plans; evaluate results
- Write technical documents including work instructions, batch records, SOP’s and training documents for manufacturing operators
- Train manufacturing 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 QC team to evaluate new processes and methods at scale
- Own all aspects of tech transfer for new products including post-release QA
- B.S. or M.S. in Biochemistry, Molecular Biology, Microbiology, Bioengineering, or related field
- 3-5 years industrial experience in biotechnology product development and/or technical transfer
- Thrives in fast paced work environment
- Extremely organized and detail oriented
- Highly motivated and strong work ethic
- Excellent written and verbal communication skills
- Proven ability to launch products in a biotechnology or life sciences company
- Ability to work in a fast paced, team environment
- Background in molecular biology techniques including PCR, DNA purification, DNA quantification, molecular cloning, NGS sequencing.
- Experience with statistical analysis.
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.