Hikma Pharmaceuticals USA Inc.

  • Manager, Analytical Development

    Job Location US-OH-Columbus
    Posted Date 6 days ago(12/6/2018 10:37 AM)
    Job ID
    2018-5008
    Job Function
    Research and Development
    Shift
    Cherry Hill First Shift
  • Overview

    Leads an analytical group in support of the development of a manufacturable multi-source pharmaceutical product that is bioequivalent. Ensures that project time-lines and quality/regulatory requirements are met.

     

    Ensures that rugged methods are developed and validated. Monitor laboratory compliance to procedures/guidelines, cGMP.

    Responsibilities

    • Leads an analytical group and ensures that, for the assigned projects, all the necessary analytical tasks for development, registration, filings and responses to deficiencies and other testing are correctly identified and executed within the project time-lines. Ensures that results, potential issues/delays are timely communicated to the project team and management. Oversees group work assignment. Participates in definition of project strategies and time-lines.
    • Supports ANDA/IND/NDA regulatory submissions by developing suitable specifications, ensuring that rugged analytical methods are applied, ensuring that analytical information are shared within the project team and with internal customers. Defines and implements plans of action to respond to deficiencies. Responsible for the analytical documentation necessary for filing.
    • Provides leadership, evaluates performance, oversees employee development , and mentors scientists within the group to minimize risk to the business and maximize value
    • Checks analytical data generated by the group. Ensures quality, accuracy and compliance status of the data generated.
    • Prepares and reviews relevant DPs, SOPs, guidances, protocols and reports to support laboratory GMP functions in compliance with FDA/regulatory guidances.
    • Drives changes monitoring current systems, processes, procedures and working toward improving and refining them.
    • Ensures that the group maintains compliance with cGMPs, cGLPs, FDA, ICH guidelines, SOPs, and DEA regulations. Ensures laboratory cleanliness.
    • Communicates with direct reports, management, project teams, , and internal and external customers about projects and business related matters.
    • Participates in discussions on product strategies.
    • Interacts efficiently with Operation personnel (Quality, Launch, Stability) to ensure that technology transfer is performed. Ensures support to launch and commercial activities.
    • All other duties as assigned.

    Qualifications

    • Ph. D. in Chemistry, Pharmaceutics or other Scientific disciplines with at minimum of 6 years of experience in the pharmaceutical industry or
    • MS in Chemistry, Pharmaceutics, or other Scientific disciplines with a minimum of 8 years of experience in the pharmaceutical environment, or
    • BS in a scientific discipline with a minimum of 10 years of experience in a pharmaceutical environment.
    • A minimum of 3 years of proven coaching, and mentoring scientists and/or 3 years on a supervisory role is required along with demonstrated ability to motivate, evaluate and develop co-workers.
    • Demonstrated knowledge of analytical development, validation, analytical instrumentation, chemistry along with the ability to troubleshoot analytical methods.
    • Basic knowledge of organic/inorganic chemistry and basic understanding of toxicology is required.
    • Project management skills are required.

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