• Research Officer

    Glenmark Pharmaceuticals Inc., USA (Monroe, NC)


    Research Officer

     

    Department: Tech Transfer

     

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    POSITION SUMMARY

    Glenmark is actively seeking a Research Officer to join the growing team in Monroe. The Research Officer Tech Transfer team will provide technical support to scale up/site transfer manufacturing processes and commercialize new products at Monroe and external manufacturing sites. This role is responsible for performing project activities for new product introductions at Monroe site and site transfer of the products to external manufacturing sites. This will include activities such as scale-up batches, exhibit/registration batches, and process validation Batches.

    OVERALL JOB RESPONSIBILITIES

    Responsibilities

    Results Expected/ Target

     

    Prepare protocols/Batch Records for scale-up, Engineering Batches for the new products.

     

    Create gap analysis reports, risk assessment reports.

     

    Support manufacturing investigations relevant to OOS, OOT, and incidents as required, including data evaluation, root cause analysis, identification, and establishment of the root cause using a data-driven and science-based approach

     

    Engineering and/or scale-up batches, exhibit/registration batches and Process Validation Batches support in Manufacturing area.

     

    Cleaning validation and/or equipment Qualification support for the new products.

     

    Understanding of pilot studies, scale-up, DOE, process optimization, technology transfer, troubleshooting

     

    Responsible for detecting gaps in the manufacturing process, potential for process improvements /optimization, and ability to work in teams to ensure resolution of technical issues in manufacturing and ensure adequate process capability and process control for all products

    Documentation:

    1.Should be capable of drafting Batch Records and Protocols/Reports for new products.

    2. Should understand and interpret the DoE Reports, QbD reports for successful process scale up.

    3. Expected to guide Cross functional Teams on New Product-s process criticalities.

    4. Should be capable to dealt with Warehouse and Project Manager on timely delivery to the site.

    5. Work closely with R&D team, MSAT, QA, QC for smooth tech transfers of the oral dosage forms, Injectable and Pre-filled syringes

    6. Support Site Transfer activities for oral dosage forms, Injectables and PFS.

    7. Should be self-Driven and self-planned to drive the CFTs on New Projects.

     

    Equipment Trials and necessary documentation readiness for Oral Dosage forms, Injectables

     

    Should be able to draft the necessary documents

     

    Responsible for site transfer activities at external Manufacturing sites and Third-Party testing labs.

     

    Should guide CMOs and Third-Party Testing Labs.

    KNOWLEDGE, SKILLS AND ABILITIES

    Education (degree / diploma)

     

    Minimum-B.S. Pharmaceutical Sciences / B.S. Engineering preferred MS Pharmaceutical Sciences / MS Engineering.

    Experience

    3+ years in Pharmaceutical Industry (FR&D/PDL/Tech. Services) is preferred

     

    Knowledge and Skills (Functional / Technical)

    Technical Skills:

    Excellent technical protocol/report writing and review skills

     

    Technical coordination with R&D/MSAT/Production team for execution of Development/Exhibit/Process Validation batches/New Launches.

     

    Prepare Batch Records, Protocols and Reports as per guidelines and regulatory requirements

     

    Pilot studies, scale-up, technology transfer and troubleshooting

     

    process performance qualifications, continued process verification (CPV), and continuous process improvement.

     

    Technical Investigation and Root Cause Analysis

     

    Excellent technical report writing and review skills

     

    Good communication and documentation skills (English, written and oral), Presentation skills, Project Management, Flexibility

     

    Deep understanding of Aseptic Manufacturing and Oral Dosage Forms unit operations

    Knowledge:

    Scale up, Site Transfer and Commercialization of New Products (Injectable, Oral dosage forms).

     

    Knowledge of regulatory guidelines in the pharmaceutical industry

     

    START YOUR APPLICATION (https://apply.hrmdirect.com/resumedirect/ApplyOnline/Apply.aspx?req\_id=3570883&source=3570883-CJB-0)