Position: Sr. Specialist – Analytical Chemistry
Karyopharm Therapeutics is a clinical-stage pharmaceutical company focused on the discovery and development of novel first in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases.
The Sr. Specialist – Analytical Chemistry will participate in the analytical method development, validation, and transfers at the clinical stage. The individual is also responsible for the analytical review of methods, protocols, and reports for validation and stability studies. Assist in preparation and review of regulatory filings from early development to commercialization. The individual will also manage CMOs and CROs to meet the program timelines and objectives.
- Thoroughly analyze results and methods, solve analytical problems, troubleshoot assays and meet regulatory expectations for analytics applied to small molecule drug substances and drug products
- Review and approve method development reports as well as method validation protocols, data, and reports
- Review and assess trends observed in batch histories and stability testing for API and DP to set appropriate specifications throughout development.
- Assist with CMC activities to support regulatory filings (IMPD, CTA, IND/NDA) for Karyopharm development programs
- Support communication with external vendors via conference calls and/or emails, etc. as needed
- Assure that source data and information is maintained and traceable. Assist in the management of the analytical reference standards and impurities
- Assist and support the stability program with cross-function work flows
- Minimum BS in Life Sciences or related science degree required
- Minimum 5 years of experience in Analytical Chemistry within the Pharmaceutical or Biotechnology industry in clinical or commercial environment
- Detail oriented and able to prioritize tasks as directed
- Hands on benchwork experience of general analytical techniques including: LC, GC, KF, dissolution, DSC, TGA, NMR, etc.
- Previous experience with method development and method validation is preferred
- Small molecule experience is required
- Ability to work with all levels of organization.
- Knowledgeable in CGMP regulations and ICH or other industry guidance.
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