Senior Director of Quality Control

Ratio Therapeutics, Inc.•West Valley City, UT

2d•$205,000 - $240,000•Onsite

About The Position

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.

Requirements

PhD and 10+ years, MS and 15+ Years, or BS and 20+ years in Quality Control within Life Sciences, with a minimum of 5 years specifically in radiopharmaceutical manufacturing.
Proven track record in analytical method development and validation through the commercial drug product lifecycle.
Advanced degree in chemistry, or related scientific discipline.
Thorough knowledge of ICH Q2, USP <1225>, 21 CFR Part §211 and 21 CFR §11.
Direct, hands-on experience using and administering Waters Empower 3 CDS in a GMP QC laboratory, including method set-up, integration parameters, and secure data review/approval workflows.
Direct, hands-on experience implementing and/or administering Waters NuGenesis LMS (or similar LIMS), from user requirement definition through validation and routine use.
Comfortable working as a hands-on laboratory leader while a broader QC team is being recruited, with the expectation of building, mentoring, and delegating to that team over time.
Demonstrated experience managing professional-level SMEs and building lab cultures centered on integrity and continuous improvement.

Nice To Haves

Preferred experience developing PET/therapeutic radiopharmaceutical analytical testing methodology

Responsibilities

Lead the end-to-end lifecycle of analytical methods, from initial development through phase-appropriate validation (ICH Q2) and into routine commercial use.
Oversee the IQ/OQ/PQ of specialized QC instrumentation, including HPLC with radioactivity detectors, Gamma Spectrometers, instant thin layer chromatography, and Gas Chromatographs.
Design and manage stability studies to support shelf-life claims for both drug substances and finished drug products, accounting for radiolytic degradation.
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.
Implement and maintain "Data Integrity by Design" for all lab informatics (LMS, CDS), ensuring all electronic records are contemporaneous, attributable, and secure.
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.
Act as the primary subject matter expert during FDA, state, and NRC inspections, defending analytical methodologies and microbiological control strategies.
Author and review relevant sections of IND/NDA/ANDA filings, ensuring technical data accurately reflects the validated state of the QC laboratory.
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.
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.
Develop and manage the QC department budget, including capital expenditure on lab buildouts and the procurement of reagents and reference standards.
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 schedule.
Serve as business owner for Waters Empower chromatography data system (CDS), including user administration, system suitability configuration, and integration with QC workflows.
Lead the configuration and implementation of Waters NuGenesis LMS for sample management, stability pulls, and data review/approval, ensuring alignment with data integrity requirements.
Partner with IT and vendors to qualify, maintain, and continuously improve the CDS and LIMS environments.