What are the responsibilities and job description for the Associate Director/Director Analytical Program Lead 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 Sr. Director, Analytical Development, the AD/Director, Analytical Program Lead will be responsible for implementation of analytical strategy to support Viridian’s development pipeline and ensure sustained clinical supply. The APL will oversee analytical workflows for multiple programs at all stages of development. This role entails significant collaboration with internal cross-functional groups as well as oversight of external CDMO/CRO partners. Primary responsibilities include:
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):
- Provide technical guidance, strategic and tactical direction and oversight for Analytical Development projects from pre-clinical through commercialization
- Manage activities including method assessment, development, transfer and validation to support release and stability testing of drug substances and drug products
- Provide detailed review and approval of analytical methods, development reports, validation protocol and reports, stability protocol, etc.
- Manage and provide technical guidance to support investigations, quality events and development studies at CDMO/CROs
- Author and review technical reports, technical data packages and relevant CMC sections for regulatory filings (INDs, IMPDs, NDAs, MAAs, etc.)
