Reagent Manufacturing

1 month ago

Boulder, United States Foresight Diagnostics Full time

About the Company
Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado. 

About the Role

The Reagent Manufacturing QC Specialist will be responsible for supporting daily operations for Foresight’s reagent manufacturing to supply the research, development and production laboratories with materials required to perform testing. This position will follow and maintain processes and documentation in compliance with regulations appropriate for the intended use of the materials (i.e. CLIA, ISO). This position will work cross functionally with internal members of the R&D, Production, Bioinformatics, and Supply Chain and Procurement teams. This is a full-time position working standard business hours, but may require the flexibility to work diverse schedules, including evenings, weekends, and holidays. This position reports to the Reagent Manufacturing & QC Lead/Manager. 

  

Responsibilities 

Coordinate with cross functional teams on daily and weekly planning to ensure materials and volumes are available to support timely execution of regulatory studies, research, translational medicine, and clinical testing 

Support developing processes for manufacture, quarantine, verify and release of reagents for research and clinical testing needs in compliance with appropriate regulations

Create, maintain and conduct annual reviews of reagent manufacturing and QC SOP and batch records

Perform and review QC testing according to work instructions and batch records 

Work with cross functional laboratory leads, supply chain, and quality to develop and maintain a process to receive, test, and release reagents to production inventory 

Ensure traceability of reagents by following Foresight’s established SOP for lot number assignment and record-keeping 

Bring technical issues to leadership and present solutions, when possible

Collaborate with Supply Chain, R&D, and Production to establish a reagent manufacturing schedule based on forecasted quarterly demand

Draft and review validation protocols and reports for reagent manufacturing, as appropriate

Maintain inventory of reagents to support testing needs.

Perform reagent manufacturing day to day operations to meet business objectives without negative impact to cross functional teams, TAT, or quality

Assist in  the development, collection, and reporting of performance metrics including critical to quality and continuous improvement metrics for release of materials and biobanking.

Assist in monitoring, maintaining, and improving the efficiency of processes 

Other job related duties and projects as assigned.

Skills and Qualifications

2+ years in laboratory environments

A bachelor’s degree: BA/BS. 

Hands-on experience in quality control, molecular biology, and/or clinical laboratory testing (NGS preferred) and technical understanding of quality control as it relates to regulated environments.  

Strong organizational skills.

Analytical and operational skills with an ability to identify meaningful insights from complex data.

Self-starter who thrives in ambiguity in a fast-paced environment.

Ability to deliver on end-to-end projects with a high level of autonomy.

Exceptional interpersonal skills with ability to work inclusively and collaboratively with a diverse population, both internally and externally.

Model behavior to promote teamwork, professional staff interactions, and a safe work environment. 

 

This role is offering an hourly rate between $25.00-29.25, and is eligible for equity offerings.

Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match. 

The application deadline for this position is August 15, 2024

You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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