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JOB TITLE: Associate Director of Analytical R&D and Quality Control

DEPARTMENT: Analytical R&D and Quality Control

SUPERVISOR: Director of Quality Assurance and Regulatory Affairs

Description:

The Associate Director of Analytical R&D and Quality Control will oversee and manage the operations, facilities, and systems of the Norac Pharma ARD/Quality Control Department in support of the development, manufacture, testing, and release of Active Pharmaceutical Ingredients, Intermediates, and API Starting Materials.

Responsibilities:

  • Primary Responsibilities:
    • Develop and validate new analytical methodologies or exploit and validate established analytical methodologies to determine the structure of unknown organic materials, to separate complex mixtures, to characterize novel compounds (including primary and secondary standards), and / or to quantitate any desired analytes.
    • Maintain a high level of working knowledge in the major areas of spectroscopy (especially multi-dimensional NMR, mass spec, X-ray diffraction, IR, and UV/Visible) and chromatography (IC, GC, LC, and HPLC). Remain current in electronic and mechanical troubleshooting for commercial analytical instrumentation. Keep abreast of analytical software developments. Conduct relevant literature searches.
    • Manage a cGMP analytical group that can provide consistently superior analytical measurements. Provide direct supervision to analytical staff members for day-to-day tasks and responsibilities.
    • Oversee and mentor the Norac Pharma Quality Control Department.
    • Establish necessary quality systems to ensure cGMP compliance.
    • Maintain complete laboratory records of the analytical group in accordance with accepted laboratory practices, SOPs, and regulatory requirements.
    • Evaluate inquiries and Tech Packages from potential clients. Interface with process R&D and API Operations on feasibility at pre-proposal stage of inquiries.
    • Generate proposals, progress reports, project summaries, Development Reports, Tech Packages, SOPs, and PowerPoint-presentations as needed.
    • Assist with the preparation / review of regulatory documents.
    • Work with contract organizations as necessary.
    • Key accountability to track, manage and improve the cost of analytical services.
    • Guide cost-effective enhancement of Norac Pharma analytical services (through new technologies, in house or subcontracted).
  • Safety Responsibilities:
    • Actively support the Environmental, Health & Safety programs of Norac to ensure employee and plant safety and security.
    • Work with management, technical personnel, and EHS Director to ensure compliance with OSHA and other safety regulations (e.g., hot work, lock out tags, confined workspace, etc.).

Education / Experience / Personal Requirements:

  • Minimum BS in Chemistry (or equivalent scientific discipline).
  • 10+ years work experience in the analytical chemistry of organic compounds is required, with significant focus on structure elucidation of complex compounds using multiple techniques.
  • High-level working knowledge in NMR, IR, Mass Spectroscopy, X-ray crystallography, UV/Visible, IC, GC, and HPLC.
  • Working knowledge of wet chemical and electrochemical analytical techniques.
  • Possesses advanced knowledge of cGMP/GLP/FDA principles and is able to apply these principles in the analytical development and quality control environment.
  • Working knowledge and implementation of USP/EP/ICH guidelines and practices.
  • Candidates must have a proven track record of management experience (managing at least 6 staff).
  • Ability to motivate others and show past effectiveness.
  • Good interpersonal and leadership skills.
  • Ability to operate in a decentralized environment.
  • Ability to manage multiple tasks and prioritize work.
  • Self-motivated with strong organizational and time management skills.
Thank you for your interest in Norac Pharma however we regret that we are unable to acknowledge all submissions and only those candidates who we invite for interview will be considered to be confirmed applicants.