• Director, Analytical Development

    Job Locations US-MA-Bedford
    Posted Date 3 months ago(3/20/2019 12:13 PM)
    Job ID
    2019-1215
    # of Openings
    1
    Category
    Development
  • Overview

    Direct the planning, implementation and execution of Analytical Development activities by providing creative analytical expertise and leadership. This position is responsible for analytical chemistry method development, qualifications and validations, routine testing, and method transfer; as well as similar activities related to other physical testing. To accomplish this, oversight of both in-house and outsourced testing resources is required. This role also has overall accountability for meeting product development teams’ testing needs, supporting associated regulatory filings, as well as managing the testing of clinical product.

    Responsibilities

    Hire, mentor, and guide Analytical Development team members
    •Identify and manage analytical contract research organizations
    •Provide creative insights for analytical method development to support new drug product concepts
    •Manage phase-appropriate method qualifications and validations, as well as method transfers to Quality Control
    •Manage routine testing to support development project objectives, this may include batch release testing of clinical material (primarily Phase 2 and earlier)
    •Although primary testing focus is analytical chemistry (i.e. HPLC, Karl Fischer, etc), oversee other product performance testing such as container closure and implant dimensions
    •Interact with cross-functional personnel to meet project objectives, timelines, and integrate technical information into regulatory filings
    •Develop budgets and resource planning to achieve product development plans/goals
    •Direct supervision of the Analytical Development team
    •Direct responsibility for Analytical Development laboratory and management of analytical contract research outsourcing

    Qualifications

    •Bachelor’s degree in chemistry, or related sciences and expertise in the field. Advanced degree preferred
    •15+ years of industry experience in pharmaceutical analytical chemistry, small molecule experience strongly preferred
    •Track record of successfully developing, mentoring, and supervising technical staff
    •Experience with pharmaceutical Regulatory Affairs analytical requirements and expectations, including writing related submissions for both Drug Substance and Drug Product analytical sections
    •Organic chemistry / small molecule analytical development knowledge is required
    •Knowledge of phase appropriate GMP requirements and related investigational new drug applications (IND) and new drug applications (NDA). Knowledgeable in USP/EP compendia, GLP and ICH guidelines
    •Ability to provide strong hands-on leadership and communication skills
    •Experience with both Drug Substance and Drug Product testing requirements
    •Experience preferred with unique or complex drug dosage forms, such as long-acting injectables or drug delivery
    •Experience with Waters and Agilent instruments, and Empower software preferred
    •Safe laboratory practices

     

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