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ElevateBio Associate Director, Quality – Viral Vector in Waltham, Massachusetts

Title: Associate Director, Quality ? Viral Vector

Location: Waltham, MA

Reports to: Vice President, Quality Assurance

The Role:

The Associate Director, Quality ? Viral Vector will be responsible for the quality operational management of the viral vector activities at ElevateBio. This role will oversee batch record generation, review, and approval of viral vector operations, including Adeno-Associated Virus (AAV) and Lentivirus (LV) at our state-of-the-art BaseCamp facility. The Associate Director is responsible for driving the organization towards a culture of innovation, collaboration, best practice, accountability, and efficiency. The primary objective is to ensure manufacturing processes are capable, compliant, in control, and continuously improved.

Here?s What You?ll Do:

  • Responsible for clinical batch disposition. Ensure review of batch data, including batch records, deviations, and other quality systems as applicable to determine acceptability of product disposition

  • Serve as the Quality lead to support product Risk Assessments, supporting the identification of Quality risks and appropriate mitigation plans to achieve compliant solutions

  • Review and approve internal deviations, CAPA, and Change Control, performing Failure Mode and Effect Analyses, root cause analyses, and CAPA effectiveness check as required

  • Develop, monitor and improve quality processes which are scalable and sustainable to meet the organizations growing needs

  • Foster a quality mindset throughout the company by ensuring consistent, risk-based and innovative thought processes are employed to advise and make decisions

  • Lead the management review of quality compliance and operational KPIs at the manufacturing facility; ensure timely mitigation of unfavorable trends

  • Quality oversight of Technical Transfers between development/GMP

  • Provide strategies to address compliance gaps or determines enhancements to cross-functional quality systems

Requirements:

  • Minimum of 10 years pharmaceutical manufacturing, packaging, or laboratory experience including at least 7 years in clinical and or commercial quality operations

  • Expert knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy products

  • Strong knowledge of current industry trends and ability to use the latest technologies

  • Working knowledge of: Aseptic practices and clean room design/operations, auditing techniques.

  • Strong leadership skills with the ability to thrive in a high throughput environment

  • Ability to lead and manage projects/teams within corporate objectives and project timelines

Why join ElevateBio?

ElevateBio is accelerating the future of biotechnology; developing the next-generation of cell, viral and regenerative medicine therapeutics for the treatment of severe diseases. We have launched a revolutionary new model that integrates innovators, infrastructure and capital to effectively develop cell, gene and related therapies for patients with severe and life-threatening disorders. With plans for a cutting-edge laboratory and manufacturing center already underway, we're building a world-class organization lead by expert talent with bench-to-bedside capabilities. ElevateBio is also a leader in corporate philanthropy and has taken a pledge to donate a portion of product sales to fund promising cancer research and to support cancer care in the developing world.

At the heart of the ElevateBio platform is ElevateBio Base Camp, a state-of-the-art research, development and manufacturing center for innovation in the Greater Boston Area to be staffed with a world-class team of scientists.

Our Vision:Next-generation product development for advanced therapies supported by global bench-to-bedside expertise shared across our portfolio of companies

ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person?s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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