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 

 

 

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