Senior Manufacturing Process Engineer

Why join Freenome?

Freenome is a high-growth biotech company on a mission since 2014 to create tools that empower everyone to prevent, detect, and treat their disease. 

To achieve this mission, Freenome is developing next-generation blood tests to detect cancer in its earliest, most treatable stages using our multiomics platform and machine learning techniques. Our first blood test will detect early-stage colorectal cancer and advanced adenomas.

To fight the war on cancer, Freenome has raised more than $1.1B from leading investors including a16z, GV (formerly Google Ventures), T. Rowe Price, BainCapital, Perceptive Advisors, RA Capital Management, Roche, Kaiser Permanente Ventures, and the American Cancer Society’s BrightEdge Ventures. 

Are you ready for the fight? A ‘Freenomer’ is a mission-driven employee who is fueled by the opportunity to make a positive impact on patients' lives, who thrive in a culture of respect and cross collaboration, and whose work makes a significant impact on the company and their career. Freenomers are determined, patient-centric, and outcomes-driven. We build teams around divergent expertise, allowing us to solve problems and ascertain opportunities in unique ways. We are dedicated to advancing healthcare, one breakthrough at a time.

About this opportunity:

The Senior Manufacturing Process Engineer, as a member of the Technical Operations team, oversees the development of manufacturing processes and procedures.  Specific areas of focus include working with manufacturing, quality, and product engineering to achieve continuous product and process improvements. The Senior Manufacturing Process Engineer will have a leading and influential role to bring product through development and into production.  The Senior Manufacturing Process Engineer will drive the development and deployment of robust manufacturing processes meeting metrics on safety, cost, quality and supply.  This scientist will be impactful by leveraging their proficient knowledge of product and process development, manufacturing scale up, compliance, continuous process improvement and troubleshooting processes in the design transfer, commercialization, and optimization of novel in vitro diagnostic tests.

What you’ll do:

• Manage design, implementation, system integration, verification and validation of manufacturing processes and equipment.
• Take ownership of all manufacturing processes and equipment.  Troubleshoot and find solutions to problems.
• Provide new ideas for process improvements.  Test ideas and provide recommendations in a timely manner.
• Take charge of the transfer of new products from R&D to commercial manufacturing.
• Responsible for developing processes, structured BOMs, well-written manufacturing instructions and setup of manufacturing lines.
• Define and own key performance indicators (yield. CpK, cost, etc) is support of the new product development process.  Driving improvement action plans if such actual performance is not meeting established targets.
• Qualify and deploy appropriate metrology into production. 
• Support and monitor new product development for adherence to the internal quality management design control system and compliance to all ISO, FDA and QSR regulations
• Provide regulatory compliance input to the Operations team on quality issues arising during process improvements and risk updates.
• Facilitate alignment among development, supplier quality, and supply chain groups to ensure product suppliers are effectively developed.
• Conduct root cause analysis to support nonconformance and CAPA investigations.

Must haves:

• Bachelor of Science in Mechanical, Electrical, Bio Medical or related field
• 8 years professional experience as a manufacturing or process engineer
• 8 years experience leading technical teams
• Experience with molecular diagnostics
• Experience developing, characterizing and troubleshooting reagent manufacturing processes
• Demonstrated ability to understand and effectively work across multiple functions
• Demonstrated leadership skills, including ability to organize, clarify and influence others
• Effectively articulate (verbally and in writing) results and conclusions to technical and non-technical personnel
• Use of data analysis to drive improvement - working knowledge of statistical tools  and manufacturing methodologies (FMEA, RCA, SPC, DOE, Lean, Six Sigma)
• Strong documentation skills
• Take initiative and have the ability to conduct hands-on work
• Possess the ability to handle multiple tasks with superior attention to detail

Nice to haves:

• Working knowledge of FDA Regulations and Good Manufacturing Practices, ISO 13485 and CLIA regulations
• Method validation 
• Automation

Benefits and additional information:

The US target range of our base salary for new hires is $136,000 - $210,000. You will also be eligible to receive pre-IPO equity, cash bonuses, and a full range of medical, financial, and other benefits dependent on the position offered.  Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education. We invite you to check out our career page @ https://careers.freenome.com/ for additional company information.  

Freenome is proud to be an equal opportunity employer and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Applicants have rights under Federal Employment Laws.  

• Family & Medical Leave Act (FMLA)
• Equal Employment Opportunity (EEO)
• Employee Polygraph Protection Act (EPPA)

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