ratiotx

ratiotx

Senior Director of Quality Control

West Valley City, Utah · Director

Sponsorship not specifiedDetected 20 days ago
ComplianceProduct ManagementAccountingProcurementGMPFDA RegulatoryResearchMass SpectrometryLeadershipCollaborationProblem SolvingMentoring

About the role

  • About Ratio Therapeutics Ratio Therapeutics is committed to improving and extending the lives of cancer patients without sacrificing their quality of life.
  • About the Position Ratio is seeking an on-site Senior Director of Quality Control (QC) for our Salt Lake City, Utah radiopharmaceutical manufacturing facility.

Responsibilities

  • 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.
  • 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.
  • CMC Support: Author and review relevant sections of IND/NDA/ANDA filings, ensuring technical data accurately reflects the validated state of the QC laboratory.
  • Resource Planning: Develop and manage the QC department budget, including capital expenditure on lab buildouts and the procurement of reagents and reference standards.
  • Design and manage stability studies to support shelf-life claims for both drug substances and finished drug products, accounting for radiolytic degradation.
  • 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.
  • Develop and manage the QC department budget, including capital expenditure on lab buildouts and the procurement of reagents and reference standards.

Requirements

  • Preferred experience developing PET/therapeutic radiopharmaceutical analytical testing methodology
  • 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.
  • The annual base salary for this role is expected to range between $205,000.00 and $240,000.00. This range is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. The actual base salary offered will depend on a variety of factors, including qualifications, work experience, skills, level of education attained, certifications or other professional licenses held, the location in which the applicant lives and/or from which they will be performing the job, and other job-related factors permitted by law.

Nice to have

  • 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.

Skills

  • About Ratio Therapeutics
  • Ratio Therapeutics is committed to improving and extending the lives of cancer patients without sacrificing their quality of life.
  • These enabling platform technologies to have resulted in an emergent pipeline of novel therapeutic candidates.
  • Join us in our quest to become the leading innovator in radioligand therapy and improve the lives of cancer patients and their families.
  • About the Position
  • Ratio is seeking an on-site Senior Director of Quality Control (QC) for our Salt Lake City, Utah radiopharmaceutical manufacturing facility.

Compensation

  • The annual base salary for this role is expected to range between $205,000.00 and $240,000.00.

Benefits

  • 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.
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