Biologics Quality Assurance Manager

4 days ago


Waltham, Massachusetts, United States Lifelancer Full time

Job Title: Biologics Quality Assurance Manager

We are seeking a Biologics Quality Assurance Manager at Lifelancer, a talent-hiring platform in Life Sciences, Pharma, and IT.

Estimated Salary: $100,000 - $160,000 per year.

About the Company

Mural Oncology is a clinical-stage oncology business focused on discovering and developing immunotherapies that may meaningfully improve the lives of patients with cancer.

About the Job

  • Manage commercial stability program, including establishment of shelf life.
  • Oversee stability programs to ensure timely testing, real-time trending, and generation of stability reports.
  • Develop and execute QC strategies for method qualification, transfer, and validation.

Responsibilities

  • Author, review, and approve various documents, including SOPs, CoAs, technical reports, stability reports for regulatory filings, change controls, deviations, CAPAs, OOSs, and OOTs.
  • Perform quality reviews and approval of PPQ and commercial product manufacturing documentation.

Requirements

  • Demonstrated experience in external QC oversight, including managing QC teams and/or initiatives.
  • Proficiency in data analysis and KPI development to support quality metrics and continuous improvement.
  • Experience in development and CMO/CTL operations, including oversight of contracted organizations and auditing experience.


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