Lupin Pharmaceuticals (Company Headquarters)

  • (50025) Analytical Research and Development - Manager

    Job Locations US-FL-Coral Springs
    Posted Date 3 weeks ago(4/30/2018 1:42 PM)
    Job ID
    2018-2295
    # of Openings
    1
    Category
    R&D
  • Overview

    The Pharmaceutical Development Manager will oversee a project team of chemists in the laboratory conducting standard and advanced laboratory activities including stability testing of drug product and product characterization studies.

    Responsibilities

    • Supervise stability programs for regulatory submission, participating in laboratory activities as required
    • Plan laboratory activities on a weekly basis and ensure project timelines are met consistently
    • Develop and communicate project plans and goals to the group
    • Propose and implement processes and new technologies that lead to increased efficiencies and quality of laboratory activities. Drive the continuous improvement process.
    • Analyze data, identify trends and perform statistical analysis.
    • Write protocols, methods, standard operation procedures, and submission documents when required. Design experimental studies and write reports.
    • Provide expert support for analytical technical issues, analyzing data, identifying solutions, and implementing recommendations.
    • Independently develop statistical design of experiments.
    • Participate in project activities and support project timelines and proactively contribute to meeting the team objectives. Communicate effectively with team members and internal or external customers. Work and communicate effectively with other functional groups.
    • Ensure that members of the group are trained on relevant methods, policies and procedures. Verify that training records of group members are updated at least twice a year. Conduct performance reviews of group members and provide them with regular feedback. Support the personal development of group members.
    • Mentor and assist members of group
    • Immediately address any issues of non-GLP or GMP compliance as well as complacency regarding EHS policies and standards
    • Troubleshoot lab equipment issues or breakdowns
    • Conduct investigations of out of trend or out of specification results
    • Prepare documents such as methods, specifications, SOP’s, protocols and reports

    Qualifications

    • Minimum Bachelor’s Degree in Chemistry or related discipline
    • 3+ working in a supervisory role in the laboratory, specifically in Research and Development
    • 12+ years working as an R&D Chemist for a pharmaceutical company
    • In-depth knowledge of pharmaceutical and inhalation technology
    • Knowledge of instrumental techniques such as HPLC, GC, IR, UV, and DSC, and other related analytical technologies and/or broad knowledge of development of MDI/DPI/Nasal products.
    • Knowledge of Regulatory requirements and experience in preparing regulatory submissions
    • Knowledge of GMP/ GLP. Good understanding of USP methodologies and ICH guidelines.
    • Above average written and verbal communication skills
    • Ability to establish and maintain working relationships with co-workers
    • Superior organizational, problem-solving and multitasking skills, with the ability to pick-up and learn new tasks quickly
    • Strong interpersonal skills; capability to work with a team as well as with a great deal of autonomy

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed