A summary of the responsibilities
· Direct Analytical Development activities for the company’s proprietary AAV and lentivirus based programs.
· Work closely with external CROs/CDMOs, collaborators, and/or partners through IND filing, clinical trials, and ultimate commercialization.
· Assist in the effort to efficiently evaluate, select, and manage contract service providers (CDMOs and CROs). This will include analytical method development, method transfer, method qualification / validation, generation of standards and key reagents, comparability and stability studies.
· Partner with Project Management to ensure that assay development timelines are in place and aligned with the project’s overall objectives.
· Build, mentor, and lead AD team as company need grows.
· Assist in developing and/or providing critical review of development documents (batch records, experimental data, protocols, reports, analytical methods, SOPs, etc.). Support the creation, maintenance, improvement, and routine use of Quality Systems. Contribute to the generation and protection of company intellectual property.
· Assist in writing and reviewing technical sections for company’s global regulatory submissions related to programs. Partner with Project Management to ensure submission timelines are established and met.
· Assist in adhering to a CMC budget for assigned program activities, including the preparation of cost estimates for new work. Work with the Office Manager to track invoices and proactively verify versus work performed. Partner with Finance to periodically review and report on the status of project spend versus the approved budget. Recommend appropriate budgetary adjustments in conjunction with changing project scope and timelines.
· Contribute technical 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.
At Spirovant, the successful candidate will be a highly creative leader and problem solver, who thrives in a “get it done” type of environment. (S)he will have the following mix of personal and professional characteristics:
· 8+ years of relevant experience with roles of increasing responsibility over time
· PhD (or equivalent) in Virology, Biochemistry, Pharmaceutical Sciences, Analytical Chemistry, Chemistry or closely related fields preferred. Individuals without a PhD but with significant work experience may also be considered.
· Strong technical knowledge across analytical development. This should include a deep understanding of and experience working with:
o AAV and/or Lentiviral platforms
o Assay development for vector identity, potency (including cell-based assay), purity, etc.
o Analytical tools including PCR, ELISA, Chromatography, and AUC
· Experience working closely with Process Development teams
· Extensive knowledge of GLP and cGMP regulations, ICH guidelines, and the CMC content of global regulatory submissions for gene therapy
· Experience with method transfer and qualification / validation
· Ability and willingness to travel as necessary to meet essential initiatives
· Strong interpersonal skills, a collaborative working style
· Intellectual agility - able to pivot based on shifting priorities and balance multiple projects seamlessly
· Adaptability, flexibility, independence and resourcefulness to lead major initiatives while also willing to roll-up-sleeves and multi-task in order to thrive in a growing environment
· Ability to successfully function in a flat yet rapidly growing organization