Director, Analytical Development
Our client is a leading, high growth biotechnology company. They have asked us to assist them in a search for a Director, Analytical Development.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Directs analytical development activities for the company’s proprietary based programs.
- Works closely with external CROs/CDMOs, collaborators, and partners through IND filings, clinical trials, and ultimate commercialization.
- Assists in the effort to efficiently evaluate, select, and manage contract service providers. This will include analytical method development, method transfer, method qualification and validation, generation of standards and key reagents, comparability and stability studies.
- Partners with project management to ensure that assay development timelines are in place and aligned with the project’s overall objectives.
- Builds, mentors, and leads analytical development team as company need grows.
- Assists in developing and providing critical review of development documents.
- Supports the creation, maintenance, improvement, and routine use of quality systems.
- Contributes to the generation and protection of company intellectual property.
- Assists in writing and reviewing technical sections for company’s global regulatory submissions related to programs. Partners with Project Management to ensure submission timelines are established and met.
- Assists in adhering to a CMC budget for assigned program activities, including the preparation of cost estimates for new work. Works with the Office Manager to track invoices and proactively verify versus work performed. Partners with Finance to periodically review and report on the status of project spend versus the approved budget. Recommends appropriate budgetary adjustments in conjunction with changing project scope and timelines.
- Supports the company’s initiatives for pipeline expansion. Partners with internal and external experts to evaluate and select partnering opportunities related to potentially new development programs.
- A PhD (or equivalent) in virology, biochemistry, pharmaceutical sciences, analytical chemistry, chemistry, or a closely related field is preferred. Individuals without a PhD but with significant work experience may also be considered.
- 8+ years of relevant experience with roles of increasing responsibility over time is required.
- Must have strong technical knowledge across analytical development. This should include a deep understanding of and experience working with AAV and Lentiviral platforms, assay development for vector identity, potency (including cell-based assay), purity, and analytical tools including PCR, ELISA, Chromatography, and AUC.
- Must have experience working closely with process development teams.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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