Adverum Biotechnologies, Inc. is a mission-driven clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases with the aspiration of developing functional cures to restore vision and prevent blindness. Leveraging the research capabilities of its proprietary intravitreal (IVT) platform, Adverum is developing durable, single-administration therapies designed to be delivered in physicians’ offices to eliminate the need for frequent ocular injections to treat these diseases. By overcoming the challenges associated with current treatment paradigms for these debilitating ocular diseases, Adverum aspires to transform the standard of care, preserve vision, and create a profound societal impact around the globe.
Note to Recruiters and Agencies
All recruiter and agency inquiries must go through Adverum’s internal Talent Acquisition team. Unsolicited resumes sent to Adverum will be considered property of Adverum. Adverum’s Talent Acquisition team must expressly engage agencies for any requisition. Direct contact with hiring managers by agencies will not be tolerated and may affect your ability to work with Adverum in the future.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 cross-functionally with the QC team. 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 related 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 validation
- Experience 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.
$144,457 - $155,605 a yearThe 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.At Adverum, Inclusion and Diversity are at our core.
We believe in the power of being your authentic self. We strive to create a space that allows everyone in our Adverum Community to not only feel safe but also 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. Apply for this job
