Senior Director, Technical Operations

Employer
Freenome
Location
South San Francisco, CA
Posted
May 05, 2022
Ref
5217286002
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time

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 Senior Director of Technical Operations role at Freenome will lead a team of scientists and engineers focused on product transfer into Laboratory Operations, ensuring operational readiness for commercial launch, leading continuous improvement, and maintaining compliance with regulatory requirements.  

  • Direct successful implementation of laboratory and manufacturing processes inclusive of automation, LIMS, and QC.
    Lead Technical Operations Team to support the introduction of new product into manufacturing/production and maintain compliance.
  • Support and monitor new product development for adherence to the internal quality management design control system and all ISO, FDA and QSR regulations.
  • Provide regulatory compliance input to the Operations team on quality issues arising during process improvements and risk updates.
  • Manage pre-production design assurance/quality engineering activities as they relate to product lifecycle development.
  • Verify Configuration Management and Risk Analysis records are properly addressed, accurate, and maintained.
  • Provide support for nonconformance investigations as required.
  • Support CAPA investigations, reviews, approvals, and/or CAPA plan implementations as required.
  • Plan, develop, organize, implement, direct and evaluate the organization's laboratory operations and performance.
  • Ensure that testing systems developed and used for each of the tests performed in the laboratory meet all aspects of test performance, which includes the pre-analytic, analytic, and post-analytic phases of testing.
  • Ensure that the test methodologies selected have the capability of providing the quality of results required for patient care; meet accuracy standards; and lab personnel are using test methods for accurate and reliable results.
  • Oversee the development of the organization's plans and programs in evaluation of long-range planning and regulatory action on operational performance.
  • Oversee resourcing and budget requirements for introduction of new systems into operations
  • Perform other duties as required.

What We’re Looking For

  • MS or relevant work experience in Mechanical Engineering, Molecular Biology, or related fields
  • 8+ years developing and implementing laboratory processes in a regulated environment
  • 3+ years of direct experience managing interdisciplinary teams
  • Experience with laboratory information management systems (LIMS) integration and scheduling of automated platforms
  • Excellent problem solving and reasoning skills
  • Excellent written and oral communication skills
  • Demonstrated track record of high-throughput scale-up and optimization of systems
  • Must be able to effectively articulate (verbally and in writing) results and conclusions to technical and non-technical personnel


Preferred

  • Ph.D or relevant work experience in Mechanical Engineering, Molecular Biology, or related fields
  • Experience in a regulated environment (CLIA/CAP/NYSDOH/FDA)
  • Experience developing automated methods for biofluids and nucleic acids 

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.