• Scientist II/III – Preclinical Development

    Job Locations US-MA-Bedford
    Posted Date 4 weeks ago(7/29/2019 7:24 AM)
    Job ID
    2019-1247
    # of Openings
    1
    Category
    Development
  • Overview

    Ocular Therapeutix is seeking a scientist to be a lead in the planning, coordinating, executing, and documenting pre-clinical studies which support clinical development efforts. Additionally, assist in the pharmaceutical development and manufacture of sustained drug release prototypes for evaluation in preclinical studies. These preclinical studies are performed at contract research organizations (CROs) assessing the pharmacokinetics and pharmacodynamics (PK/PD) and safety of lead drug product formulation candidates. This person will further design and execute studies working collaboratively with management and project team members supporting the companies sustained release hydrogel technology platform.

    Responsibilities

    •Design, execute, and document preclinical studies with emphasis on product performance in PK/PD and safety
    •Design, perform and analyze formulation and process development studies for novel sustained release drug products
    •Manufacture and characterize drug product materials accordingly to GLP/GMP to support preclinical and early phase clinical studies
    •Collaborate effectively while participating in cross-functional product development teams to communicate study design, project status, data analysis and program plan to project team members including senior management
    •Work within team to meet project goals, with a specific emphasis on leading effort to achieve preclinical goals and clinically relevant research
    •Ability to identify/select, participate in vendor qualification, and coordinate activities at preclinical contract research organizations (CRO)
    •Generate technical documents including preclinical study procedures, protocols and reports to support regulatory submissions
    •Planning, execution, documentation and analyses of experiments
    •May mentor and lead junior staff supporting drug product development activities dependent upon level and experience

    Qualifications

    •BS, MS or PhD in Chemistry, Biology, Pharmaceutics, Biomedical or Chemical Engineering, Animal Sciences or related discipline with >5 years of experience in drug product development
    •Experience in pre-clinical research, and preferably acting as study coordinator and familiar with GLP regulations, requirements and standard study outputs
    •Able to screen, select and work collaboratively with a CRO in support of preclinical studies
    •Experience in supporting drug product elements of preclinical and early stage clinical studies
    •Experience in CMC, sustained release formulations, different routes of administrations and ophthalmic indications is desirable
    •Fundamental understanding of physicochemical properties as related to drug delivery and drug product formulation design
    •Builds strong relationships with peers and cross functionally with partners outside of the team to enable higher performance
    •A hard-working, passionate about science, team player that can effectively collaborate in a dynamic, cross-functional team environment

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed