Massachusetts Green Jobs

MassHire JobQuest Logo

Job Information

Karyopharm Therapeutics Inc. Bioanalytical Scientist, CMC in Newton, Massachusetts

SUMMARY:

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.

RESPONSIBILITIES:

  • 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

QUALIFICATIONS:

  • 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.

ID: 2021-1761

Street: 85 Wells Ave.

DirectEmployers