• Formulation Sr. Scientist

    Job Locations US-CA-San Diego
    ID
    2019-1129
    Category
    Scientific
    Type
    Full-Time
  • Overview

    The Formulation Sr. Scientist will provide technical leadership for the development of pre-clinical and early clinical stage candidates using our proprietary technology for the delivery of small molecule and peptide/protein therapeutic agents.  The successful candidate will be expected to drive programs from inception through preclinical manufacture/screening, technology transfer to selected CDMO’s, early cGMP manufacture working closely with Quality and CMC counterparts as well as any necessary analytical method development, specification development, and assessment of stability data/programs.

    Responsibilities

    • Develop and refine Xeris’ XeriJect technology platform (sterile suspension/paste in oil), including formulation, process and scaleup.
    • Develop robust phase appropriate preclinical formulations to screen commercial opportunities
    • Prepare and supply finished drug product (non-GLP, GLP) for internal and external studies
    • Conduct formulation optimization through Design of Experiments
    • Oversee the development of analytical methods to support the formulation development activities and early phase specifications for pre-clinical and clinical supplies.
    • Design stability studies, analyze and summarize analytical data, contribute to storage condition recommendations and product expiry/shelf life
    • Contribute to the identification/qualification of sterile fill-finish CDMO’s and facilitate technology transfer activities for non-GMP and cGMP drug product manufacture
    • CDMO management for early phase CTM manufacture
    • Write, review and approve technical protocols and reports
    • Write, review and edit appropriate sections of Regulatory submissions
    • Represent Product Development at cross functional Core Team interactions
    • Perform other duties as required
    • Up to 25% travel required

    Qualifications

    • Ph.D. in Chemistry or related scientific field with a minimum of 9 years of experience working within formulation development, analytical method development and CMC
    • Experience with the development of sterile parenteral products
    • Experience in particle engineering and sterile suspension and paste manufacturing preferred.
    • Demonstrated experience in preclinical and early clinical development
    • Solid understanding of GLP and GMP regulations with a working understanding of ICH and FDA guidelines
    • Experience managing CDMO’s at all stages of development
    • Working understanding of analytical method development activities, HPLC/UPLC experience, experience using compendial methods for the characterization of parenteral products
    • Direct experience with the development of early phase clinical CTM specifications
    • Experience writing NDA, IND and other regulatory submissions
    • Preferred Combination product experience
    • Solid written and oral presentation skills
    • Communicates clearly and effectively across multiple functions and levels to foster a friendly collaborative work environment
    • Excellent problem-solving skills
    • Ability to be flexible and thrive in a fast-paced environment
    • Proactive team player who can also work independently

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