As Sr. Manager of the Process Development team, the candidate will:
- Manage the development and transfer of new NGS products and applications to manufacturing
- Oversee process improvement projects within the current manufacturing pipeline end to end from conception to operator training to ensure seamless transfer with minimal impact on production
- Interact cross functionally with internal teams to communicate technical details and completion timelines to drive decision making
- Gain thorough understanding of end-to-end production workflows including lab processes and relevant software
- Work closely with R&D to understand new product designs and transform process knowledge into high throughput production methods for product manufacturing
- Define product specifications, processing parameters and operational boundaries
- Collaborate with R&D, Automation, QC, QA, Lab Software, Ecommerce and Operations to develop, verify and validate all new processes
- Plan and manage project timelines and resourcing and provide updates and feedback to project leadership.
- Review experimental plans, analyze large data sets, and report study results and recommendations both verbally and in written formats
- Review technical documents including verification and validation test plans and reports for tech transfer and work instructions, batch records, SOP’s and training documents for manufacturing operators
- Develop test plans, protocols, batch records, and reports to ensure designs and processes meet product specifications, regulatory requirements and standards
- Oversee all aspects of tech transfer for new products including post-release QA
- Ph.D. in Biochemistry, Molecular Biology, Microbiology, Bioengineering, or related field
- 8+ years industrial experience in biotechnology product or process development and/or technical transfer to GMP, CLIA, or ISO labs
- Prior experience in a NGS company required
- Experience developing and launching products (ie reagent kits)
- Prior managerial experience with supervising junior staff
- Extremely organized and detail oriented
- Ability to excel in dynamic fast paced business environment, demonstrated ability to self-motivate and manage multiple priorities
- Experience with Tableau, Spotfire, or JMP
- Experience with LIMS including requirement specification is preferred
- Demonstrated record of successful technology transfer from late R&D concepts into customer-facing products
- Experience with automation platforms such as Hamilton/Biomek/Tecan or Echo is a plus
- Background in molecular biology techniques including PCR, DNA purification (column and bead based), DNA quantification (absorbance and fluorescence), NGS sample preparation, DNA assembly (Gibson, Golden Gate, Restriction Enzyme), and 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.
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.
San Francisco applicants: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.