Lupin Pharmaceuticals (Company Headquarters)

  • (50013) Scientist II - Analytical

    Job Locations US-FL-Coral Springs
    Posted Date 1 month ago(1 month ago)
    Job ID
    2018-2319
    # of Openings
    1
    Category
    Analytical Research and Development
  • Overview

    Lupin is among the top five pharmaceutical companies in India and is an innovation led transnational pharmaceutical company developing and delivering a wide rage of branded & generic formulations, biotechnology products and APIs globally.  Lupin is committed to bringing innovative products for the healthcare professionals to improve the health and well-being of individuals.

     

    We are looking for a Scientist for our Analytical group.  Below are the details:

     

    Independently designs, and conducts standard and advanced laboratory activities with all the routine analytical instruments including the related softwares. Have some knowledge and experience in pre-formulation characterization studies for raw materials. Have basic knowledge in inhalation products. Leads and supports the analytical method development and validation/verification as per USP and ICH guidelines as well as in-house SOPs. Initiates investigations and data reviews, contributes to planning of analytical resources, and coaches and trains junior scientific staff.

    Responsibilities

    • Independently design, and conduct method development for raw materials as well as for finished products. ,
    • Independently design, conduct and lead method validation/verification for raw materials as well as for finished products as per USP and ICH guidelines as well as in-house SOPs.
    • Independently design, conduct and lead method transfer for raw materials as well as for finished products.
    • Write protocols, methods, reports, standard operation procedures, and submission documents when required.
    • Analyze data, identify trends and perform statistical analysis. Present data, recommendations and conclusions to senior management on a regular basis.
    • Troubleshoot technical issues, analyze data, identify solutions, and implement recommendations.
    • Evaluate and introduce new technologies; be capable of generating new practical ideas; possess strong understanding of experimental design.
    • Develop statistical design of experiments with minimal supervision.
    • Write regulatory submission modules and any other documents to support submission and product approval.
    • Work and communicate effectively with other functional groups and across global respiratory R&D sites.
    • Independently lead small project tasks.
    • Establish and maintain effective relationships with team members.
    • Conduct lab work in accordance with SOPs; follow Lupin safety rules and procedures.
    • Comply with all Lupin Corporate guidelines and policies.

    Qualifications

    • PhD in Pharmaceutical Sciences or Analytical Chemistry or related discipline with 2+ years, MS with 8+ years research experience in pharmaceutical or related field. 
    • Must possess good knowledge in modern analytical methodologies (UPLC/HPLC, GC, UV, FTIR etc.) including related softwares.
    • Good knowledge of global regulatory requirements as applied to orally inhaled and nasal products (OINDPs).
    • Knowledge of aerosol characterization methodologies (Cascade Impaction, Laser Diffraction techniques etc.) and analytical chemistry.
    • Decent understanding of USP methodologies and ICH guidelines. Deep knowledge of the FDA cGMP requirements as they apply to the Pharmaceutical industry.
    • Strong English language skills including writing ability and oral communication. Experience with writing of GMP documents (SOP, STP, protocols and reports).

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