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Senior Process Engineer - San Francisco, United States - Freenome
Description
Why join Freenome?Freenome is a high-growth biotech company developing tests to detect cancer using a standard blood draw.
To do this, Freenome uses a multiomics platform that combines tumor and non-tumor signals with machine learning to find cancer in its earliest, most-treatable stages.
Cancer is relentless. This is why Freenome is building the clinical, economic, and operational evidence to drive cancer screening and save lives. Our first screening test is for colorectal cancer (CRC) and advanced adenomas, and it's just the beginning.Founded in 2014, Freenome has ~500 employees and more than $1.1B in funding from key investors, such as the American Cancer Society, Andreessen Horowitz, Anthem Blue Cross, Bain Capital, Colorectal Cancer Alliance, DCVC, Fidelity, Google Ventures, Kaiser Permanente, Novartis, Perceptive Advisors, RA Capital, Roche, Sands Capital, T.
Rowe Price, and Verily.At Freenome, we aim to impact patients by empowering everyone to prevent, detect, and treat their disease. This, together with our high-performing culture of respect and cross-collaboration, is what motivates us to make every day count.
Become a Freenomer
Do you have what it takes to be a Freenomer? A "Freenomer" is a determined, mission-driven, results-oriented employee fueled by the opportunity to change the landscape of cancer and make a positive impact on patients' lives.
Freenomers bring their diverse experience, expertise, and personal perspective to solve problems and push to achieve what's possible, one breakthrough at a time.
About this opportunity:
At Freenome, we are seeking a highly skilled and motivated Senior Process Engineer to help grow the Freenome Technical Operations team.
The primary focus of the position is to critically evaluate laboratory/manufacturing/QC processes for variation and improvement for the multiomics colorectal cancer IVD product.
The ideal candidate will drive the development and deployment of robust processes meeting metrics on safety, cost, quality, and supply.
This engineer will impact the business by leveraging their knowledge of product and process development, scale up, compliance, continuous improvement, and troubleshooting in the commercialization and sustainability of novel in vitro diagnostic tests.
You are passionate about building efficient and high-quality operations and you will have a significant impact on the continued growth of an organization dedicated to changing the entire landscape of cancer.
What you'll do:
Support the clinical lab by troubleshooting laboratory workflows involving NGS chemistry, protein immunoassay, laboratory equipment, and informatics infrastructure
Collect, analyze, and interpret process data to identify trends, patterns, and areas for improvement
Own NCR/CAPA actions to resolve process issues
Define and own key process indicators in support of consistent quality of lab processes (capacity utilization, equipment downtime, CAPEX, SPC,CPK, etc.)
Develop data dashboards and conduct data driven investigations to provide oversight of clinical lab operations
Draft and own key quality documentation for processes (Process validation/IQ/OQ/PQ, work instructions, troubleshooting guides)
Own continuous improvement within the clinical lab to reduce test turnaround time, reduce COGS, and improve product quality
Provide technical training and support to clinical/manufacturing
personnel on new processes, equipment, and technologies
Support the development of new products for Tech Transfer. This includes product pilot/design transfer planning and development of operational requirements
Define validation plans/protocols for material assessment for robust supply chain management
Must haves:
Bachelor's in Chemical Engineering, Biotechnology, Physics, or a related scientific field with at least 7 years of experience or A Master's and 5 years of experience
Understanding of NGS workflows, cancer biology, and/or genetics
Full understanding of process management/improvement philosophies (LEAN, Six Sigma, DMAIC, 8D)
Solid background in process statistical analysis and data-driven decision making
Full competency in data analysis and visualization tools, such as JMP, Minitab, or Excel; Bonus for Python or R
Strong communication and interpersonal skills to collaborate effectively with cross-functional teams; scientists, engineers, etc.
Demonstrated ability to lead projects and investigations independently
Knowledge of GMP (Good Manufacturing Practices), FDA regulations, ISO 13485
Experience working with lab automation equipment (liquid handling, robotic arms etc.)
Proven ability to deconstruct complex processes down to first principles in order to evaluate process risk and root cause analysis
Nice to haves:
Experience with developing Liquid handling methods such as Hamilton/Tecan
Comfortable scripting in Python/R
Experience transferring products from Development to Production
Benefits and additional information:
The US target range of our base salary for new hires is $128,000 - $195,000.
You will also be eligible to receive pre-IPO equity, cash bonuses, and a full range of medical, financial, and other benefits depending 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 @ 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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