What are the responsibilities and job description for the Manager, Quality Control, Tech Services Systems position at Viridian Therapeutics, Inc?
At Viridian, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets.
Reporting to the Associate Director of Quality Control, the Manager, Quality Control, Tech Services, will establish and maintain QC control systems including assay performance, reference standards, and critical reagent. The QC Manager will support other QC Tech Services tasks. This position works closely with other functions within Viridian and external CMO/CTLs.
This role is based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week.
Responsibilities (including, but not limited to):
- Establish and maintain QC systems to monitor and trend reference standards, assay performance and critical reagents across Viridian’s portfolio
- Review reference standard generation, protocols, and reports. Track and trend reference materials. Oversee RS inventory management across CMO/CTLs
- Trend and review assay control parameters
- Drive change controls including reference standard changes and method changes
- Perform trend analysis including testing data to support specifications for clinical and commercial drug substance and drug products and prepare the reports
- Review method qualification/validation protocols and reports. Review sampling protocols
- Manage release data across multiple programs through data review, trending, and generation of CoAs
- Author and manage OOS investigations and Deviations. Troubleshoot issues and drive resolutions
- Collaborate with internal stakeholders and CMO/CTLs for QC testing-related topics to ensure compliance and timeliness
- Write, revise, and review Quality Control SOPs
- Author CMC sections for regulatory filings
- Assist in Audits with QA
- Perform other duties as required
