Method Validation SME

Adverum Biotechnologies is seeking a Method Validation Subject Matter Expert (SME) to play a crucial role in our commitment to quality and compliance. In this role, you will leverage your extensive validation expertise to ensure that our processes meet the highest standards of cGMP/GxP compliance and support our operational excellence.

• Lead and manage the validation process for equipment and systems in compliance with cGMP/GxP standards.
• Develop and execute comprehensive validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Collaborate with cross-functional teams to ensure effective execution of commissioning activities for a variety of equipment and systems.
• Oversee vendor factory acceptance tests (FAT) and system acceptance tests (SAT), ensuring thorough review and documentation.
• Manage GMP documentation related to validation activities, ensuring data integrity and adherence to quality standards.
• Provide expertise in CAPA, deviation management, and change control processes.
• Serve as a thought leader and mentor within the organization to promote best practices in validation.
• Facilitate effective communication with stakeholders to ensure timely project delivery and customer satisfaction.
• Maintain up-to-date knowledge of industry regulations and trends to ensure compliance and innovation in validation practices.

• Education: Bachelor’s degree in Life Sciences, Engineering, or a related field; advanced degree preferred.
• Experience: Minimum of 10 years in the biotechnology or pharmaceutical industry, with a strong focus on method validation and cGMP/GxP compliance.
• Technical Skills: Proficient in creating Validation Master Plans (VMP), User Requirement Specifications (URS), Risk Assessments (RA), and Validation Summary Reports (VSR).
• Software Proficiency: Experience with Veeva, Master Control, SAP, and other electronic document management systems.
• Leadership: Proven ability to lead diverse teams and foster an inclusive working environment.
• Communication: Strong interpersonal and communication skills to engage effectively with stakeholders at all levels.
• Problem-Solving: Excellent project management skills with the ability to manage schedules, logistics, and vendor relationships efficiently.

Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.  

At Adverum,InclusionandDiversityare at our core. We believe in the power of being your authentic self. We strive to create the space which allows for everyone in our AdverumCommunityto not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation.