Adverum Biotechnologies, Inc., a wholly owned subsidiary of Eli Lilly and Company, is looking for a Quality Control CTL Manager to join our team in our Redwood City office. This position reports to the Quality Control Advisor. The QC CTL Manager works in providing oversight on all QC Release and Stability sample testing at various contract testing labs (CTLs) and contract manufacturing organizations (CMOs) as well as supporting method transfer and method validation activities at CTLs and CMOs.
This individual will be a crucial member of the Quality Control team, contributing to the development and performance Quality Control (QC) methods, systems, policies, processes, procedures and controls as they relate to the analytical testing of clinical materials.
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 Adverum's property. 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.
What You’ll Do:
- Manage all QC Release and Stability sample testing activities at all CTLs, including but not limited to, sample and reagent shipment coordination, shipment temptale review, updated test method review/approval, advise on lab scheduling and test priority, support problem solving activities at CTLs for test directives, support OOS/OOE/OOT/Atypical lab investigations, final test data COA review/acceptance.
- Manager/support method transfer and method validation activities at CTLs and CMOs, including but not limited to, protocol review/approval, reagent shipment coordination, method validation design and document review/approval, validation data packet evaluation, final report review/approval.
- Author and revise internal SOPs, forms, and documentation related to CTL management, data review, and lab investigation activities.
- Support CTL and CMO lab audit activities if needed.
- Participate in internal audits, external inspections, and quality system assessments by providing documentation and subject‑matter expertise.
- Collaborate cross‑functionally with QC, QA, Manufacturing, Supply Chain, and Facilities to improve processes, reduce risks, and strengthen compliance.
- Contribute to continuous improvement initiatives to streamline laboratory workflows and enhance data integrity.
About You:
- Bachelor’s degree in a scientific discipline (Biology, Chemistry, Biochemistry, or related field).
- Minimum 4–6 years of work experience in a GMP analytical laboratory and/or QC environment.
- Prior CTL management experience is preferred
- Strong understanding of cGMP requirements and regulatory expectations for biotechnology and pharmaceutical QC operations.
- Experience with LIMS, electronic inventory systems, or sample tracking databases.
- Familiarity with stability programs and chain‑of‑custody workflows.
- Strong organizational skills with exceptional attention to detail and documentation accuracy.
- Excellent communication skills and ability to work cross‑functionally.
- Demonstrated problem‑solving ability and adaptability to shifting priorities.
- Proficiency with MS Office and laboratory equipment software.
About Us:
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.
Skills Required
- Bachelor's degree in a scientific discipline
- 4-6 years of work experience in a GMP analytical laboratory and/or QC environment
- Prior CTL management experience
- Strong understanding of cGMP requirements
- Experience with LIMS, electronic inventory systems, or sample tracking databases
- Familiarity with stability programs and chain‑of‑custody workflows
- Strong organizational skills with exceptional attention to detail
- Excellent communication skills and ability to work cross‑functionally
- Demonstrated problem‑solving ability and adaptability to shifting priorities
- Proficiency with MS Office and laboratory equipment software
What We Do
Adverum Biotechnologies (NASDAQ: ADVM) is a 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. Adverum is evaluating its novel gene therapy candidate, ixoberogene soroparvovec (Ixo-vec, formerly referred to as ADVM-022), as a one-time, IVT injection for patients with neovascular or wet age-related macular degeneration. 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.
