Hikma Pharmaceuticals USA Inc.

  • Scientist II, R&D

    Job Location US-OH-Bedford
    Posted Date 1 month ago(12/19/2018 5:05 PM)
    Job ID
    2018-5041
    Job Function
    Research and Development
    Shift
    None
  • Overview

    Formulation scientist responsible for the preparation and execution of experiments, data analysis and interpretation in a parenteral research and development setting.

    Responsibilities

    • Performing pre-formulation studies to build a robust understanding of the to-be-developed formulation.
    • Working with senior scientists to prepare and execute experimental designs, including data analysis and interpretation.
    • Planning and coordination development activities with analytical and process engineering colleagues.
    • Working with analytical experts to evaluate results from various formulation studies.
    • Engaging with various groups and technical services within operations and regulatory affairs to incorporate feedback during product development activities.
    • Authorship of technical and development reports, including technology transfer and regulatory submission documents. Where thoroughness and correctness are critical to successful transfer of products to operations sites.
    • Collaborating with process engineering on the optimization and scale-up of the manufacturing process

    Qualifications

    • Knowledge of formulation development, materials characterization, process development, and scale up of sterile products.
    • Experience of Quality by Design (QbD) development principles is preferred.
    • Knowledge of common analytical techniques (HPLC, GC, etc.).
    • Knowledge of FDA and ICH guidelines and requirements of regulatory submissions.
    • Strong systematic and methodological approach to problem solving and troubleshooting.
    • Strong oral and written communication with clear awareness of efficient meeting and teleconferencing etiquette.
    • Ability to multitask and prioritize assignments and willingness to work in a cross-functional team environment.
    • Self-motivated, project ownership with ability to work under pressure to meet deadlines.
    • Computer literacy required, including e-mail and fundamental computer navigation. Proficiency in the use of Microsoft Office products including Word, Excel and PowerPoint.
    • BSc with 5 years’ formulation development experience;
    • MSc with 3 years’ formulation development experience; or
    • PhD a minimum of 1 year of industrial experience

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