• Manager, Production

    Job Locations US-MA-Bedford
    Posted Date 2 weeks ago(6/7/2018 4:20 PM)
    Job ID
    2018-1078
    # of Openings
    1
    Category
    Operations
  • Overview

    Responsible for supervising clinical and commercial manufacturing operations. Ensure production operations are conducted in accordance with regulatory and cGMP compliance, while delivering to the production plan of record.  Instill a culture of continuous improvement within production operations, and foster team growth environment. Collaborate with Regulatory/Quality, Facilities, and Development with regards to project plans and the successful production execution of late phase clinical, new product launch and sustainable commercial manufacturing activities. 

    Responsibilities

    • Establish plans and deliver on the established Production Operation’s annual goals and objectives.
    • Define necessary corrective and preventative action in response to internal, regulatory, and customer audit requirements as well as deviation investigation.
    • Instill a culture of continuous process improvement with a quality focus. Pursue industry “best practices” associated with clinical and commercial production operations.
    • Manage daily production operations in late phase clinical, new product launch and commercial manufacturing.
    • Review Master Batch Records, SOPs, Qualification/Validation protocols and reports, and other essential cGMP documents.
    • Write and revise Standard Operating Procedures and other operational documents as needed.
    • Work with counterparts in Quality Assurance and Quality Control to release material in a timely fashion.
    • Provide appropriate coaching, development, and associated performance management for the production operations staff.
    • Perform other duties as required.

    Qualifications

    • Bachelor’s Degree in Scientific, Engineering or related discipline
    • 10 years of experience in pharmaceutical drug product manufacturing with specific responsibilities in supervision and new product introduction
    • In-depth knowledge of cGMPs and working in a regulated environment
    • Experience writing and developing SOPs and other regulatory documentation
    • Proficiency in Microsoft Office Applications
    • Excellent organization, communication and analytical skills are required
    • Mobility and ability to lift up to 50 lbs.
    • Must be able to work in a cleanroom environment.

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