Karyopharm Therapeutics Inc. Bioanalytical Scientist, CMC in Newton, Massachusetts
We are seeking Bioanalytical Scientist with hands on experience in analytics to support CMC development of biotherapeutic proteins. Responsible for the development and application of analytical methods to support recombinant protein development program from clinical to commercial. The candidate will manage CMOs and CROs to meet the program timelines and objectives, and is expected to work cooperatively with Regulatory Affairs, Pharmaceutical Sciences, and the Quality Team.
Manage analytical testing at CMO/CROs development, optimization, and validation of bioanalytical methods for large molecule therapeutics
Oversee the characterization of biological drug candidates including ID by peptide mapping, bioassay and immunoassay
Analytical lead for the data review of drug substance and drug product for in-process, release, and stability testing for Phase 1 clinical studies through commercialization
Oversee analytical method validation protocols/reports
Analytical technical lead for transfer of analytical methodology to contract laboratories and external vendors
Evaluate assay performance and data trending to support on-going studies and specification justification
Represent the group in project team meetings through formal and informal presentations
BS/MS in Chemistry, Biochemistry or related field
Minimum 3+ years’ experience in Pharmaceutical or Biotechnology industry required
Must possess a solid understanding of protein chemistry and biochemistry, particularly as it relates to biotherapeutic protein drug development
Familiar with biologics process and product development and clinical/commercial manufacturing
Experience developing and performing H/UPLC (SEC, IEX, RP, HIC, HILIC), SDS-Page, CE, Karl Fisher, Osmolality, ELISA, UV-Vis, Western blot, LC/MS and GC/MS is preferred
Experience with protein characterization techniques, peptide mapping, and protein characterization assays is preferred.
Must have strong written and verbal communications skills
Must be capable of working in a fast-paced, collaborative environment and managing multiple concurrent assignments
Knowledgeable in CGMP regulations, ICH, or other industry guidance
Veeva experience a plus
Karyopharm Therapeutics is a global commercial-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.
Karyopharm Therapeutics Inc. (the "Company") is an equal opportunity employer. All qualified applicants will be considered without regard to age, race, color, sex, religion/creed, national origin, marital status, ancestry, citizenship, military, reservist or veteran status, pregnancy, sexual orientation or preference, gender identity, gender expression, physical or mental disability, genetic predisposition or carrier status, or any other category protected under applicable federal, state or local law. Consistent with its obligations under applicable law, the Company will make reasonable accommodations for qualified individuals with disabilities. If you require an accommodation in the application process, please contact a member of the Company’s Human Resources department.
Street: 85 Wells Ave.