Spirovant is looking for an experienced downstream process development experience who will have the following responsibilities:
- Accountable for all CMC activities for the company’s lead SP-2101 AAV program.
- Work closely with established external CROs/CDMOs, collaborators, and/or partners through IND filing.
- Specifically work with chosen CDMOs to ensure a scalable production process sufficient to supply through clinical proof-of-concept study.
- Author and review technical sections for company’s pre-IND meeting and IND filing.
- Support the creation, maintenance, improvement, and routine use of Quality Systems.
- Develop and/or provide critical review of development documents (batch records, experimental data, protocols, reports, analytical methods, SOPs, etc.).
- Author and review technical sections for company’s global regulatory submissions related to programs.
Additional Responsibilities include:
- Contribute technical CMC expertise in support of the company’s due diligence activities for pipeline expansion opportunities.
- Partner with other team members and external experts/consultants to critically evaluate and select in-licensing and partnering opportunities related to potential new development programs.
Requiremements include an advanced degree in a scientific discipline and 8+ years relevant experience