• Analytical Sr. Scientist

    Job Locations US-CA-San Diego
    ID
    2019-1118
    Category
    Scientific
    Type
    Full-Time
  • Overview

    The Analytical Sr. Scientist will support the development and registration of the company’s pipeline of preclinical- and clinical development-stage candidates. Defines and executes the overall analytical strategy for biologics, including leading the effort in managing and overseeing analytical method development, method qualification and transfer, and biophysical/biochemical characterization activities for recombinant antibodies and related biologic modalities. Provides leadership in developing a comprehensive analytical characterization strategy for biologics assets from pre-clinical through clinical development and commercial.

    Responsibilities

    • Define and execute overall strategy for biologics analytical development.
    • Establish the Biologics analytical core functional capabilities which includes resource planning, recruiting top talent, and setting up internal labs.
    • Lead and manage the evolution of a phase-appropriate strategy for method development, qualification and transfer for drug substance and drug product.
    • Support and manage activities performed at CROs/CDMOs associated with method development and validation, stability assessment, and release testing of drug substance, drug product and reference standards.
    • Establish product-specific QC release/stability assays, provide biochemical and biophysical analytical support for drug product characterization and manufacturing, and prepare comparability assessments associated with changes in manufacturing process, scale and/or site.
    • Lead the development and maturation of specifications for drug substance and drug product in agreement with evolving control strategies in a dynamic developmental environment.
    • Collaborate with regulatory-CMC in defining technical content, related to analytical sections, of module 3 for IND and NDA/BLA submission.
    • Co-author and review technical content of analytical sections in IND and NDA/BLA and ensure timelines are met.
    • Co-author and review responses to regulatory inquiry regarding IND, NDA, and BLA submissions.
    • Select, manage and audit CRO/CDMO.
    • Establish and implement processes to enable effective collaboration with CRO/CDMO business partners to ensure efficiency and high quality of results.
    • Identify and establish relationships with external consultants/subject matter experts to leverage knowledge and experience not available in-house.
    • Partner with Quality Assurance and Regulatory Affairs-CMC to ensure completion of appropriate documentation and maintenance of high-quality standards. 
    • Partner with Quality Control group to transfer and support analytical program in support of commercial track development programs.

    Qualifications

    • Ph.D. in chemistry, biology, biochemistry, or biochemical/bioprocess engineering or related technical discipline.
    • Minimum of 7 years of small molecule, peptides and biopharmaceutical analytical experience and exposure to all stages of biologics drug development.
    • Demonstrated track record of leading and managing biophysical/biochemical characterization of biological products, analytical methods development, CRO/CDMO management, and qualification and transfer activities.
    • Strong knowledge of CMC analytical and regulatory requirements, including establishment of product specifications, governing biologics product development.
    • Hands-on working experience in IND, NDA/BLA authoring, submission and approval.
    • Competencies: Strategic & Functional Leadership, Collaboration, Project Management, Adaptability, Problem Solving, Self-Motivated, Technical Writing and Presentation skills, Written and Verbal Communication skills, Professionalism

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