Position: Senior Specialist, Quality Control – 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.
- Review all stability testing data from studies performed for Karyopharm across all programs for drug substance and drug product.
- Establish trends and ensure data is analyzed to help understand degradation pathways and to help develop specifications.
- Review analytical release data to ensure all approved procedures were followed and all specifications were met.
- Track all non-compliance events that occur during production and testing.
- Communicate with external vendors via conference calls and/or emails, etc.
- Review and approval of protocols, reports, and data associated with stability, method validation and method transfer.
- Review, approve and assess reference standards across all programs.
- Track audit management for GMP/GLP vendors.
- Review and approve batch records for all labeling and packaging operations, as needed. Ensure proper version control and document integrity of packaging component labeling, printed labeling artworks and other assigned labeling documents.
- Assure that source data and information is maintained and traceable.
- BS in Life Sciences, Chemistry or related science degree required (Additional experience may be substituted for an advanced degree).
- Five years of experience in Analytical and/or QC within the Pharmaceutical or Biotechnology industry.
- Understanding of general analytical techniques including: LC, GC, KF, dissolution, DSC, TGA, NMR, etc.
- Small molecule experience preferred.
- Ability to work with all levels of organization and external contract service providers to ensure compliance with current regulations.
- Good understanding of product process and development, from discovery to commercialization.
- Knowledgeable in CGMP regulations and ICH or other industry guidance.
- Experience with the CMC and Regulatory Filing requirements.
- Experience with data review for accuracy, completeness and compliance, preferred.
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