This job has expired

You will need to login before you can apply for a job.

Senior Validation Scientist

Employer
Freenome
Location
South San Francisco, CA
Start date
Nov 12, 2022

View more

Discipline
Science/R&D, Biotechnology
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay
You need to sign in or create an account to save a job.

Job Details

About 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.

The Lead/Sr.Validation Scientist, as a member of the Technical Operations team, partners with lab operations, quality, regulatory, systems integrations, assay development and other functions to launch novel methods on new platforms in the realization of Freenome’s early cancer detection mission.  The Lead/Sr.Validation Scientist is part of a team of highly skilled Scientists and Engineers that are responsible for the technical and scientific launch and support of Freenome’s products.  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.

Your contribution:

  • Lead Process Validation to support the successful introduction of new products into manufacturing / production 
  • Lead team of SMEs for the optimization of new assays and processes
  • 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.
  • Drive pre-production design assurance/quality engineering activities as they relate to product lifecycle development
  • Participate in formal design reviews, ensuring design control requirements are met during each design phase
  • Develop, review, and approve verification and validation protocols and reports for completeness and accuracy
  • Facilitate alignment among development, supplier quality, and supply chain groups to ensure product suppliers are effectively developed.
  • Verify Configuration Management and Risk Analysis records are properly addressed, accurate, and maintained
  • Conduct root cause analysis to support nonconformance and CAPA investigations
  • Lead teams in pFMEA and dFMEA analysis
  • Lead continuous improvement program focusing on process optimization and standardization, scaling capacity to meet demand and cost reduction initiatives

Your background, perspective and experience: 

  • Bachelor of Science in Mechanical, Electrical, Bio Medical or related field. Advanced degree preferred.
  • 8 years experience with Medical Device manufacturing, GMP, and process validation
  • 8 years experience leading technical teams
  • Working knowledge of FDA Regulations and Good Manufacturing Practices, ISO 13485 and CLIA regulations.
  • Experienced with molecular diagnostics
  • Experienced in performing test method validation and Gage R&Rs
  • Must be able to work effectively and collaborate within cross functional teams
  • Must be able to effectively articulate (verbally and in writing) results and conclusions to technical and non-technical personnel
  • Must have strong documentation skills
  • Must take initiative and have the ability to conduct hands-on work
  • Must possess the ability to handle multiple tasks with high attention to detail

 

COVID safety:

As a condition of employment, you agree to know and comply with our COVID-19 vaccination policy requiring all employees who work on-site and/or attend work-related events to be fully vaccinated and to receive a COVID-19 booster once eligible. Company employees working on-site are required to be fully vaccinated for COVID-19 and to receive a COVID-19 booster once eligible, unless a reasonable accommodation is approved or as otherwise required by law. Absent a reasonable accommodation or legal exception, you agree to provide proof of your vaccination status and to be fully vaccinated by your first day on-site, in accordance with our policy.  If you are currently eligible for a COVID-19 booster, you also agree to provide proof of having received a booster.  If you are not yet eligible for a COVID-19 booster, you must provide proof of receiving a booster within two weeks of becoming eligible.

 

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.

 

Funding

We have raised more than $1.1B from leading investors including Perceptive Advisors, RA Capital Management, Roche Venture Fund, Kaiser Permanente, Novartis and the American Cancer Society’s BrightEdge Ventures. 

Freenomers

A ‘Freenomer’ is a mission-driven employee who is fueled by the opportunity to make a positive impact on patients' lives, who thrives in a culture of respect and cross collaboration, and whose work makes a significant impact on the company and their career. 

Freenomers are technical, creative, visionary, grounded, empathetic and passionate. We build teams around divergent expertise, allowing us to solve problems and ascertain opportunities in unique ways. Freenomers are some of the most talented experts in their fields, joining together to advance healthcare, one breakthrough at a time. 

Benefits include but are not limited to:

  • Competitive compensation 
  • Pre-IPO equity
  • Flexible PTO (exempt) and generous PTO (non-exempt) 
  • Comprehensive health coverage, including medical, dental, and vision 
  • Wellness and mental health resources, including Employee Assistance Programs (EAPs), Paid maternity and paternity leave
  • 401(k) plan 
  • $250.00 new hire stipend to enhance your home office experience
  • Plus, a variety of other perks, including pre-tax commuter benefits, two paid volunteer days per year, pet insurance, and additional discounts 

# # # 

Applicants have rights under Federal Employment Laws.  

 

Notice to agencies:

Our in-house Talent Acquisition Team manages all employment opportunities at Freenome.  Agencies and independent recruiters must be approved as a vendor by Freenome’s Talent Acquisition team before submitting candidates to any Freenome employee. 

We do not accept unsolicited resumes or biographies from agencies under any circumstances. Any unsolicited resumes sent to Freenome, including those sent to a Freenome email address or directly to Freenome employees, will be considered Freenome property. Freenome will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Freenome will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. 

Please do not contact Freenome employees directly. Compliance with this request will impact our decision to work with you. 

 

###

 

#LI-Onsite

Company

Mission

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.

Approach

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. 

Funding

We have raised more than $1.1B from leading investors including Andreessen Horowitz, Bain Capital, GV, Roche Venture Fund, Kaiser Permanente Ventures, American Cancer Society’s BrightEdge Ventures, Novartis, Verily, and more. 

Freenomers

A ‘Freenomer’ is a mission-driven employee who is fueled by the opportunity to make a positive impact on patients' lives, who thrives in a culture of respect and cross collaboration, and whose work makes a significant impact on the company and their career. 

 

Facebook     Twitter  

Find Us
Website
Phone
(650) 446-6630
Location
279 East Grand Avenue
5th Floor
South San Francisco
California
94080
United States
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert