Manager - Product Quality Operations and Stability

4 days ago

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Iovance Biotherapeutics, Inc.

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Immuno Oncology • Autologous Cell Therapy • Tumor Infiltrating Lymphocytes (TIL) • Novel Cancer Immunotherapies • cell therapy

501 - 1000 employees

Founded 2014

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Description

• The candidate will be instrumental in supporting the Amtagvi annual product quality review (APQR). • The candidate will have knowledge of and experience with quality systems and document management. • The candidate will serve as an influential change agent that is able to work collaboratively and cross-functionally with both internal and external stakeholders and management. • The Manager, Product Quality Operations and Stability, should have a good understanding of quality systems, Quality Assurance, Quality Control, analytical methodologies, and regulatory requirements across the product development lifecycle. • Must have a strong Quality mindset with knowledge of cGMP operations as well as general industry and health authority requirements for cell therapies and biologics. • Must manage problems of diverse scope and demonstrate ability to translate complex issues in a concise manner.

Requirements

• Bachelor’s degree with at least 8 years of experience in a relevant discipline (biological sciences or equivalent). • Broad knowledge of cell therapy and biologics product development with respect to stability programs, stability-indicating methods, Quality Control, and regulatory guidance. • High degree of proficiency in statistical methodology and software (e.g., JMP, Minitab) commonly used for evaluation of data generated with cell therapy products. • Able to successfully interface with cross-functional teams, network within and across functions both internally and externally, and build and maintain collaborative and trusting relationships detail-oriented and organized with strong analytical, written, and verbal communication skills with right-first-time mentality and approaches. • Ability to effectively manage multiple priorities involving aggressive timelines and consistently deliver on time. • Demonstrate sense of urgency; ability to recognize and meet time sensitive demands. • Flexible and adaptable style with an eagerness to take on challenges. • Problem solver who not only identifies issues but leads efforts to resolve them.