Karyopharm Therapeutics Inc.

  • Lead Scientist, Process Chemistry

    Job Locations US-MA-Newton
    Job ID
    2019-1371
    # of Openings
    1
    Category
    Pharmaceutical Sciences
    Type
    Regular Full-Time
  • Responsibilities

    A Lead Scientist of Process Chemistry will be responsible for the development and execution of robust, well understood process and timely manufacture of cGMP materials.  This will involve the rapid design of syntheses and isolations, in conjunction with the identification of key process parameters, relevant process controls, the origin of impurities, and the appropriate process controls. 

     

    • Responsible for process development and manufacture of drug substances under cGMP conditions at outside vendors
    • Review and interpret raw data and communicating finding to internal and external teams
    • Responsible for vendor management, including technology transfer, meeting management, timeline management, and project goals
    • Ensure that supply is planned appropriately at all nodes to prevent stock-out of key materials
    • Responsible for contracting SOWs and ensuring appropriate deliverables are on-time and in full
    • CMC subject matter expert and reviewer of relevant regulatory submissions (IND, IMPD, DSUR, NDA)
    • Program lead for process chemistry activities at Vendors
    • Collaborate with Drug Product and Analytical Development to define and execute development strategies that enable phase appropriate deliverables
    • Effectively summarize key information such as program progress, timeline updates, and risk/opportunity assessments for periodic presentation to CMC group and Quality
    • Investigate, identify root cause, and approve CAPA for manufacturing deviations
    • Assist in the writing, review, and evaluation of CMC documents during due diligence exercise and/or source documents for regulatory filings
    • Work closely with team members and Finance to ensure that budgets and actuals are managed and communicated effectively

    Qualifications

    • Ph.D. in organic chemistry with 5+ years in pharmaceutical process chemistry and GMP development
    • Strong knowledge of modern synthetic organic chemistry and process chemistry
    • Strong critical thinking and problem-solving skills
    • Ability to apply critical thinking to raw data, ensuring scientific integrity, and interpretation of results
    • Experience in cGMP manufacturing and in supporting regulatory submissions
    • Good interpersonal and organizational skills with demonstrated ability effectively to manage multiple projects
    • Experience working with all levels of management and consulting with key stakeholders. An ability to influence for greater outcomes.
    • The ability to perform under pressure, manage outsourced projects with external vendors, and work effectively in a fast pace environment
    • Working knowledge of regulatory guidelines
    • Possess strong written and verbal communication skills

    Overview

    Karyopharm Therapeutics is a commercial stage pharmaceutical company focused on the discovery and development of novel first in-class drugs, with a focus on 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. 

     

     

     

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