What are the responsibilities and job description for the Associate Director, Analytical Development position at Viridian Therapeutics, Inc?
At Viridian, we aim to advance new treatments for patients underserved by today’s therapies. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases. We strive for data-driven decisions, strategic risk-taking, and efficient use of time and funds to best position our ideas for success. We value thoughtful ideas, open communication, and transparency, and are committed to a culture that allows employees to contribute at a high level, grow their careers, and balance their personal and professional ambitions.
Reporting to the Executive Director, Analytical Development, the Associate Director, Analytical Development is primarily responsible for implementation of analytical strategies for assigned programs to support Viridian’s development pipeline and contribute to sustained clinical supply through timely analytical deliverables. This is a hands-on, individual contributor role overseeing 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.
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, and tactical direction for assigned Analytical Development projects from pre-clinical through commercialization, in alignment with broader program and functional strategy
- 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.)