Lupin Pharmaceuticals (Company Headquarters)

  • Lead Technical Writer, Production

    Posted Date 3 weeks ago(11/27/2018 9:53 AM)
    ID
    2018-2448
    # of Openings
    1
    Category
    Direct Production
  • Overview

    Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions.  Together these entities make up the generic and branded U.S. business.  Lupin has a significant generic pipeline, and a branded focus on women’s health.  Our first Research and Development facility in the US is located in Coral Springs, Florida which focuses on generic and branded orally inhaled and nasal drug products. Somerset, New Jersey is home to one of twelve commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin, as well as additional Research and Development teams.  Lupin is prided on being people-focused and centered around how impactful we are with our customers.  Dollars are not a measure of success but rather the people we help along the way.

    Responsibilities

    The Lead Technical Writer in Production oversees a team of Technical Writers and report to the Associate Director of Technical Transfer.  This is a working Lead role that will also have a workload of Production documentation.  The Lead will be responsible for dispersing assignments to ensure the team’s maximum efficiency.  The Lead will also be considered the SME for Production Documentation and should continually train and mentor the team of Technical Writers as well as ensure compliance with all GMP and FDA guidelines. 

     

    • Disperse assignments to ensure the Production Technical Writing team’s maximum efficiency
    • Train, coach, and mentor the team of Technical Writers
    • Creation and revision of batch records and SAP recipes for manufacturing and packaging of an array of products including tablets, capsules, liquids, suspensions, and powders
    • Creation and revision of batch records and Standard Operating Procedures (SOP’s)
    • Provide recommendations on packaging materials selection, suppliers
    • Calculate theoretical weights for sales from the SKU to the pallet level Manage and control manufacturing documents during multiple revisions, ensuring accuracy of the original documents and the integrated changes.
    • Prepare and ensure readiness for packaging of new product launches 
    • Implement system for palletization of pallets on packaging line including CAPE PAK diagrams in batch records
    • Coordinate studies for child resistance and develop new packaging solutions to achieve required security
    • Creation of exhibit batch records for initiation of stability for the introduction of new packaging materials
    • Selection, confirmation and implementation of packaging materials (bottles, caps, labels, shippers, cartons, blistering materials) for new packs as well as comparisons with existing materials equivalency 
    • Draft and execute protocols to test new packaging materials on existing lines and initiate stability 
    • Create and execute change controls 
    • Work with third parties to coordinate packaging activities including review and approval of records
    • Draft and execute protocols for packaging line trials or product rework
    • Work with several departments including QA/QC, Production, Marketing, Sales, Regulatory, Purchasing, and Planning on a daily basis in a GXP environment
    • Collaborate with SME’s to capture best practices and accurate documentation.
    • Organize material and complete writing assignments according to set standards regarding order, clarity, conciseness, style, terminology and SOP’s.
    • Maintain records and files of work and revisions.
    • Recommends changes to the process to enhance efficiencies and improve current processes.
    • Become familiar with production processes and methods by building productive relationships with production, engineering, validation and development personnel.
    • Observe production, developmental, and experimental activities to understand detailed operating procedures and methods to create effective manufacturing documents.
    • Train or assist in the training of new hires.

    Qualifications

    • Bachelor’s degree in a scientific discipline
    • 5+ years’ experience creating production documentation in pharmaceutical manufacturing
    • Experience leading teams preferred
    • Accuracy - Ability to perform work accurately and thoroughly.
    • Must have excellent grammatical skills and effective oral, listening, and written communication skills.
    • Adaptable to changes in work duties, responsibilities, and requirements and can manage work load.
    • Strong interpersonal skills; capability to work as part of a team with operators and other departments.
    • Detail-oriented, thorough and methodical, and excellent organizational and planning skills with ability to manage and prioritize multiple tasks while still meeting deadlines. Possesses good editorial/proofreading skills and understands and performs well the process of writing (outlining, drafting, revising, and reviewing).
    • Excellent organization skills.
    • Able to perform numerous simple and complex tasks without losing sight of overall objectives. 
    • A strong understanding of Word and Excel is critical

    Physical Requirements

    • The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in an office or manufacturing environment.

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