Quality Control CTL Manager at Adverum Biotechnologies ensuring efficient QC testing across contract labs. Collaborating with teams and managing method validation in a hybrid role.
Responsibilities
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.
Requirements
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.
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