We are seeking a passionate and talented individual to grow and lead the Process Engineering team in R&D across multiple sites to support GRAIL’s product goals. Working cross-functionally with assay, automation, software, quality, regulatory, and operations teams, you will lead the process development of various high throughput systems, and subsequent transfer into operations. You will bring an operations mindset and connectivity into R&D, helping design solutions that are fit for the end users’ needs.
- Oversee GRAIL’s R&D process engineering team with responsibilities spanning from product development and to operation support.
- Define and execute strategies to formalize robust processes to deliver technologies, workflows, and systems into production, in order to support GRAIL’s various product offerings.
- Partner closely within R&D, Software, and Lab Operations to harmonize workflow development approaches across stakeholders.
- Drive the creation of workflow and capacity modeling, ensuring systems meet operational KPIs, and can support ROI estimation for continuous improvement projects.
- Partner with Automation and Quality to deliver qualification procedures and specs to Operational Engineering teams.
- Build and maintain close coordination with Operational groups in order to drive projects supporting scale and operational efficiency.
- Set team goals, allocate resources, and empower team members to drive delivery across a breadth of programs.
- Motivate and mentor employees both within and outside their teams.
- Promote a culture of scientific curiosity and rigor, collaboration, and respect
- 10+ years of industry experience in a diagnostic, medical device, life science tools, or biopharma setting.
- BS (MS/PhD preferred) in an engineering or life sciences discipline.
- Proven track record of maturing prototype assays into operational platforms.
- Track record of delivery of processes / systems into a production environmentWorking knowledge of statistical approaches applied to process development.
- Working knowledge of techniques applied to root cause analysis and troubleshooting.
- Experience leading projects requiring broad cross-functional buy in
- Evidence of successfully building and leading high-performing engineering teams.
- Excellent oral and written communication skills.
- Working knowledge of biochemistry and molecular biology, particularly as applied to NGS-based assay.
- Experience with lab automation.
- Experience in cGMP manufacturing.
- Working knowledge of FDA 21 CFR Part 820, ISO 13485 as applied to assay development.
- Experience in developing scaled processes for regulated life sciences products (e.g., 510(k) or PMA).
GRAIL is an Equal Employment Office and Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, GRAIL has made the decision to require all U.S. employees receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.