PBI-Gordon Corporation

  • Analytical Methods Development and Validation Chemist

    Job Locations US-FL | US-Pensacola
    Job ID
    2018-1162
    Business
    Pegasus Laboratories Inc.
    Category
    Scientific Research and Development
    Type
    Regular Full-Time
  • Overview

    The primary purpose of this position is to develop and validate analytical methods, design and execute cleaning method validations, and provide analytical support for product development. This role will serve as a subject matter expert for analytical methods and technical support for analytical instrumentation.

    Responsibilities

    • Responsible for development and validation of analytical methods (Assay, Impurities, Dissolution, and Cleaning)
    • Write and execute method validation protocols and reports
    • Write and execute qualification protocols and reports for laboratory equipment
    • Coordinate validation projects and ensure all validation documentation is finalized, current and archived as required
    • Oversees development of analytical services projects; from formulations support to stability and validation
    • Must be able to understand and interpret data from formulation design to in-vitro/in-vivo performance and design experiments to support product development
    • Must be able to understand the purpose and objective of the studies to appropriately design protocols
    • Must be able to analyze and review raw data and interpret results
    • Responsible for training quality control personnel on new lab equipment, sample preparation and test procedures
    • Maintain calibration of laboratory instruments and equipment
    • All other duties as may be assigned.

    Qualifications

    • Education: BS, MS, or PhD in Chemistry or a related field from an accredited university
    • Experience: 3+ years required with advanced degree, prefer 5+ with BS degree; experience in pharmaceutical analytical method development and validations. Experience with HPLC, Dissolution, UV-Vis, GC, Cleaning Validations, and compendial (USP, FCC, EP) raw material testing
    •  Specialized knowledge or training: Must have a pharmaceutical, cGMP, background with an FDA regulated laboratory. Familiar with USP, ICH, and VICH guidelines
    •  Other Skills: Strong writing and documentation skills (cGMP, protocols, reports, OOS investigations, lab notebooks)
    •  Travel required in this position 0-10%

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