Quality Control CTL (Contract Testing Lab) Manager (Contract)
Adverum Biotechnologies, Inc., Redwood City, CA, United States
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.
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.
Compensation
$55 - $65 an hour
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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.
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.
Compensation
$55 - $65 an hour
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