Science, Pharmaceutical & Food

Senior Associate Scientist – Analytical Operations

  • Full Time
  • Remote
  • Cork
  • 41814702

Job Description

  • Specific Job Responsibilities:

    • Applies advanced level of understanding of analytical methods.
    • Selects appropriate methods and techniques in performing methods development.
    • Independently plans and executes experiments that support routine & non-routine development activities and project goals.
    • May design new experiments to support development of drug substances and drug products or techniques to test such substances.
    • May create API or drug product specifications.
    • Generation, review and approval of development & validation lifecycle documentation including change controls, risk assessments, protocols, reports etc
    • Collation of data and technical writing for submissions for regulatory filings.
    • Planning and execution of method transfer/validations, process, cleaning and analytical testing in accordance with validation protocols
    • Operates as part of a global sub team as an AO lead
    • Recommends alternatives, researches new methods and techniques and may proactively seek out senior personnel to discuss potential solutions to problems.
    • Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work.
    • Works independently and determines methods and techniques on new or difficult assignments.
    • Works on complex problems where analysis of situations or data requires comprehensive evaluation of many factors.
    • Acts as a resource for other employees within the department.
    • Task management of junior employees may be required
    • Manage group with multiple areas of responsibility and may lead a component of a project within the job family.
    • Identifies and introduces new technology and/or methods to the organization and trains junior staff.

    Skills & Expertise:

    • Develops skills in data analysis and ability to evaluate quality of data.
    • Maintains high level of expertise through familiarity with scientific literature and applies appropriately to development projects.
    • Uses strong communication skills (both verbal and technical) and interpersonal skills to communicate objectives and results.
    • Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.
    • Has scientific expertise and ability to think ahead to the next step in drug development process.
    • Working knowledge of GMPs, pharmacopoeial, regulatory requirements for analytical testing, phase appropriate standards for method validation.
    • Advanced knowledge of current Good Laboratory Practices (GLPs) and current Good Manufacturing Practices (GMPs).
    • Competent in the operation of Analytical Instrumentation including Dissolution Baths, KF, UPLC & HPLC proficient in LIMS & Empower etc.

    Typical Education & Experience

    • 11+ years of experience with BA or BS degree in Chemistry or Biology.
    • 9+ years of experience with MS degree in Chemistry or Biology

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