The Senior 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. 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. Manages the development, validation, and implementation of appropriate analytical methods at CMOs and CROs in support of drug substance and drug product development across all stages of development. Manages and leads the technical oversight and timeline of outsourced analytical activities in alignment with program objections. Manages and leads analytical method transfers and responsible for review of protocols, data, and report for clinical stages. Review and approve method development reports as well as method validation protocols, data, and reports. Subject matter expert leading technical/analytical resolution of issues related to the performance of the methods developed and analytical methods transferred to CMOs and CROs to ensure regulatory expectations are met for analytics applied to small molecule drug substances and drug products throughout clinical manufacturing. Conduct gap analyses and assessments related to CMC: analytical method development and method transfers; specification criteria for all in-process, raw material, and final product testing (i.e. stability, spike-purge studies and batch histories). 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. Lead the iStability program implementation and cross-functional work flow. 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. Initiate, implement and lead multiple programs to improve the functionality of the Analytical department and to remain current with the various government guidances. Qualifications 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 Goods understanding of process and development from discovery to commercialization Knowledgeable in cGMP regulations and ICH or other industry guidance s
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