Biologics Quality Assurance Manager
4 days ago
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 CompanyMural 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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