Job details

Senior Manager, Reagent Manufacturing & QC

Location: On-site, Boulder, CO

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 Senior Manager, Reagent Manufacturing & QC will be responsible for developing and driving daily operations for Foresight’s reagent manufacturing and quality control to supply the research, development and production laboratories with materials required to perform testing. This position will develop and maintain processes and documentation in compliance with regulations appropriate for the intended use of the materials (i.e. CLIA, ISO 13485). 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.

What You Will Do:

Lead reagent production with strong cross-functional leadership to ensure project timelines and quality objectives are met.
Build reagent operations strategy and roadmap including required capex, facilities strategy, organization, IT systems, regulatory impact, and business processes.
Ensure compliance with ISO 13485, successful annual audits and recertifications
Ensures production processes are adequately developed, documented, and performed in compliance with company procedures and external regulatory requirements.
Coordinate with LIMS and ERP stakeholders to create workflows which support the reagent manufacturing program, to include reagent lot inventory and storage.
Coordinate with cross functional teams on strategic planning to ensure materials and volumes are available to support timely execution of regulatory studies, research, translational medicine, and clinical testing.
Partner with Automation Development to build automated reagent manufacturing solutions to enable scalable operations.
Develop 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 recordkeeping.
Work closely with Supply Chain, R&D, Bioinformatics, and Production leadership to solve technical issues.
Collaborate with Supply Chain, R&D, and Production leadership 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.
Develop and maintain and report on the budget for reagent manufacture.
Manage reagent manufacturing day to day operations to meet business objectives without negative impact to cross functional teams, TAT, or quality
Manage the development, collection, and reporting of performance metrics including critical to quality and continuous improvement metrics for release of materials.
Monitor QC metrics for trend analysis and present data and solutions for problems that may adversely affect test performance to senior leadership to ensure timely resolution.
Continuously monitor, maintain, and improve the efficiency of processes.
In collaboration with Quality team leadership, execute an effective preventive and corrective action process for quality-related reagent manufacturing nonconformities.
Recruit, direct, coach, and develop talent to maintain a high level of technical and organizational expertise that works collaboratively while also cultivating, inspiring, and rewarding innovation.
Work with leadership, human resources, and recruiting to prioritize and execute on hiring needs.
This position has direct supervisory responsibilities.
Other duties as assigned

What You Will Bring:

Bachelor’s degree: BA/BS.
Experience developing ISO 13485 compliant operations.
5+ years in laboratory environments and 2+ year of leadership experience
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 CAP/CLIA and FDA regulated environments.
Strong organizational skills with an understanding of scaling and capacity planning.
Advanced 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.
Six Sigma Green Belt (Black Belt preferred) or Kaizen engineer or Lean Six Sigma certified

Compensation & Benefits:

The expected range for this position is $115,000 - $140,000 per year, 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 December 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.