Position: Analytical Manager – CMC
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 Analytical Manager is responsible for leading the analytical method development, validation, and transfers at the clinical stage. The individual is also responsible for the analytical review and approval of methods, protocols, and reports for validation and stability studies. The individual will also manage CMOs and CROs to meet the program timelines and objectives.
- Manages the development, validation, and implementation of appropriate analytical methods at CMOSs and CROs in support of drug substance and drug product development across all stages of development
- Manages the technical oversight and timeline of outsourced analytical activities in alignment with program objections
- Ability to 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
- Assist with CMC activities to support regulatory filings (IMPD, CTA, IND/NDA) for Karyopharm development programs
- Work closely with other members of Pharmaceutical Sciences, the Quality Unit (QA/QC), and Regulatory to ensure the successful GMP manufacture of Karyopharm clinical candidates and their successful progression through development to government filings with the competent authorities.
- Conducting checks and reviews of the data generated by the Contract Sites for source accuracy and traceability
- Review and assess trends observed in batch histories and stability testing for API and DP to set appropriate specifications throughout development to commercialization
- Assist in the management of the analytical reference standards and impurities
- Assist the iStability program implementation and cross-functional work flow
- BS/MS in Life Sciences or related science degree
- Minimum 10 years experience in pharmaceutical analytics for small molecule development
- Ability to work with all levels of organization and direct external contract manufacturing and service providers
- Experience in regulatory filings, specifications and controls, analytical method development and validation, and the commercialization process
- Good understanding of process and development from discovery to commercialization
- Knowledgeable in cGMP regulations and ICH or other industry guidance’s
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