Note to Recruiters and AgenciesThe Talent Acquisition / HR team manages the recruiting for all positions at Adverum. We only accept resumes from search agencies or recruiters if the Talent Acquisition / HR team has formally requested your help and have a signed agreement in place. Unsolicited resumes sent to Adverum will be considered property of Adverum. The company will not be responsible for any associated fees should Adverum hire from unsolicited resumes. We request that recruiters do not to contact or present candidates directly to our hiring managers or employees. Doing so may jeopardize the candidate’s eligibility to work on future positions. Recruiters interested in working with Adverum can submit their information to . Should we have a tough-to-fill role, we will contact you directly if you specialize in the needed area.
Adverum is looking for a Method Validation SME to join our team in our Redwood City office. This position reports into the Sr. Director, Quality Control.  This person will be working with the QC team and cross-functionally.  This individual will be a crucial member of the Quality Control team, contributing to the development and performance of Quality Control (QC) methods, systems, policies, processes, procedures and controls as they relate to the analytical testing of clinical materials.What You'll Do:Act as the technical SME overseeing the qualification, validation, and transfer of analytical methods (e.g., ELISA, quantitative PCR, cell-based assays) from Assay Development to Quality Control (QC) for gene therapy product testing.Review executed QC test records for product release, including investigation and resolution of deviations, Out of Specification (OOS) and Out of Trend (OOT) results, ensuring the appropriate corrective actions are implemented.Develop and review validation protocols, test plans, and analytical method reports, ensuring they meet GMP and regulatory standards (FDA, EMA, ICH) and are properly documented.Lead the creation and management of sample control processes for GMP release, stability testing, and additional testing needs, ensuring samples are tracked, stored, and processed in accordance with regulatory guidelines.Provide hands-on laboratory support, including routine cell culture (adherent and suspension cultures like HEK293, Sf9) and reagent preparation, to ensure the timely execution of assays and testing activities.Oversee equipment qualification (IQ/OQ/PQ) and manage maintenance, calibration, and troubleshooting activities to ensure that laboratory instruments and equipment are compliant with GMP and perform at optimal standards.Work closely with QC management to identify and mitigate risks related to QC milestones and timelines, ensuring smooth progression through validation, testing, and release processes.Work cross functionally with various teams to facilitate the timely review and approval of documents, including validation reports, protocols, and test records, ensuring compliance with internal and regulatory requirements.Serve as a key point of contact for method validation inquiries, ensuring expertise is shared across teams, while actively participating in cross-functional meetings to drive progress on QC and assay-related initiatives.About You:7-10 years of experience in a GMP environment within the biotechnology or pharmaceutical industry, with expertise in QC testing, assay validation, and method qualification.Solid knowledge and understanding of US and international regulations and guidance applicable to Quality Control and method validationExperience in quality control required.  A strong background in molecular biology is desired.Hands-on experience with analytical techniques such as quantitative PCR, ELISA, and cell-based assays, and proficiency in cell culture (e.g., HEK293, Sf9).Experience with assay transfer from R&D to QC, and managing assay qualification and validation activities. Familiarity with viral vector products (e.g., AAV) is a plus.Strong problem-solving abilities, with experience leading cross-functional teams and driving continuous improvement.Excellent interpersonal and communication skills, with the ability to collaborate effectively across teams.Flexibility to adapt to changing priorities and deadlines in a fast-paced environment.CompensationThe salary range for this position is $144,457 USD to $155,605 USD annually, with the opportunity to earn an annual bonus. This salary range is an estimate, and the actual salary may vary based on a candidate’s qualifications, including education, length of experience, location, and market data.  Employees in this position are eligible to participate in the applicable Company equity incentive award plan. The amount of incentive varies and is subject to the terms and conditions of the plan.  Employees in this position are eligible to participate in the Company’s standard employee benefit programs, which currently include the following: medical, dental, vision, 401k, STD/LTD, life and accident insurance, and either paid time off or flexible paid time off.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, nclusion and Diversityare 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 Adverum Community to 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.