What are the responsibilities and job description for the Associate Director, External Manufacturing position at Viridian Therapeutics, Inc?
At Viridian Therapeutics, 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 Director, External Manufacturing, the Associate Director, External Manufacturing is accountable for the business, relationship and operational management of all activities performed at assigned manufacturing sites within Viridian’s Contract Manufacturing Organization (CMO) network (includes biologics Drug Substance and Drug Product manufacturing, device component production, combination device assembly and commercial finished goods production). You will partner with cross functional teams, both internal and external, to ensure operational milestones supporting regulatory submissions are met and clinical and commercial supply to our patients is uninterrupted.
This role is based in our Waltham, MA headquarters. Our office-based employees follow a hybrid in-office 3 days per week schedule.
Responsibilities (including, but not limited to):
- Manage and oversee the operational execution plans for all work performed by assigned CMOs within Viridian’s network
- Serve as the primary point of contact for external manufacturing partners, cultivating strong relationships and facilitating effective communication
- Manage external spend budget for activities executed at Viridian’s CMOs; ensure accuracy of accruals, invoices, purchase orders and budget forecasting by partnering with the Technical Operations FP&A Business Partner
- Lead internal CMO core team meetings to ensure timely, transparent communication with internal stakeholders and CMOs, driving the successful delivery of CMO services
- Ensure product integrity by monitoring cGMP compliance at CMOs by implementing and conducting regularly scheduled Quality Business Reviews (QBRs) and by tracking standard Key Performance Indicators (KPIs)
- Identify business risks and implement appropriate risk mitigations
- Identify and drive continuous improvement opportunities, navigate challenges, and lead the timely resolution of issues
- Ensure that all contract terms, agreements, and performance metrics with CMOs are met, and that operations are executed in alignment with Viridian’s quality and regulatory expectations
