Senior Director of Quality Control

Senior Director Of Quality Control (Qc)

Ratio Therapeutics is committed to improving and extending the lives of cancer patients without sacrificing their quality of life. We are a team of passionate scientists, engineers, and business professionals dedicated to advancing the field of targeted radioligand therapy. To accomplish this, we utilize our proprietary TRILLIUM™ and MACROPA™ platforms: TRILLIUM™ allows fine-tuning of radioligand pharmacokinetics thereby enhancing the therapeutic index, while MACROPA™ simplifies the manufacturing process for the alpha-emitting isotope, actinium-225.

These enabling platform technologies to have resulted in an emergent pipeline of novel therapeutic candidates. We are looking for talented, dedicated, and creative individuals eager to help us advance these technologies from discovery research through clinical development. Join us in our quest to become the leading innovator in radioligand therapy and improve the lives of cancer patients and their families.

Ratio is seeking an on-site Senior Director of Quality Control (QC) for our Salt Lake City, Utah radiopharmaceutical manufacturing facility. As the Senior Director, QC, you will be the primary architect and hands-on implementer of the analytical and microbiological testing infrastructure for our new state-of-the-art radiopharmaceutical manufacturing facility. During the initial build-out, you will design the systems, workflows, and procedures that will scale with the team.

You will be supported by initial analytical and microbiology staff and cross-functional partners, with clear plans to recruit and onboard additional QC personnel as volume increases and day-to-day QC testing demand grows.

Key Responsibilities :

• Analytical Method Development, Optimization, and Validation
• Method Lifecycle Management:
  Lead the end-to-end lifecycle of analytical methods, from initial development through phase-appropriate validation (ICH Q2) and into routine commercial use.
• Equipment
  
  Qualification:
  
  Oversee the IQ/OQ/PQ of specialized QC instrumentation, including HPLC with radioactivity detectors, Gamma Spectrometers, instant thin layer chromatography, and Gas Chromatographs.
• Stability Programs:
  Design and manage stability studies to support shelf-life claims for both drug substances and finished drug products, accounting for radiolytic degradation.
• Quality Systems & Regulatory Compliance
• Document & Systems Development:
  Design, author, and implement critical QC Laboratory documentation, such as SOPs, Work Instructions, Testing Specifications, etc. to support sample workflow management and data integrity principles.
• Data Integrity & 21 CFR §11:
  Implement and maintain "Data Integrity by Design" for all lab informatics (LMS, CDS), ensuring all electronic records are contemporaneous, attributable, and secure.
• Investigations & Troubleshooting:
  Lead the technical investigation of Out-of-Specification (OOS) results, Out-of-Trend (OOT) data, and lab deviations, utilizing root-cause analysis (RCA) to drive effective CAPAs.
• Audit Readiness:
  Act as the primary subject matter expert during FDA, state, and NRC inspections, defending analytical methodologies and microbiological control strategies.
• CMC Support:
  Author and review relevant sections of IND/NDA/ANDA filings, ensuring technical data accurately reflects the validated state of the QC laboratory.
• Operational Leadership & Team Development
• Hands-On Leadership:
  Work in close collaboration with QC analysts, microbiologists, and cross-site SMEs to ensure adequate bench support, redundancy, and coverage for release testing and troubleshooting while the QC Team is being built.
• SME Management:
  Mentor a diverse team of subject matter experts, fostering a culture of technical excellence and collaborative problem-solving between the analytical and micro sub-departments.
• Resource Planning:
  Develop and manage the QC department budget, including capital expenditure on lab buildouts and the procurement of reagents and reference standards.
• KPI Tracking:
  Establish and monitor departmental metrics (e.g., sample turnaround time, lab error rates) to ensure the QC lab meets the operational demands of the production…