• Senior Manager, CMC Global Regulatory Affairs

    Otsuka America Pharmaceutical Inc. (Raleigh, NC)
    …of biologic/small molecule drug substances, drug products, and drug - device combination products. + Determine regulatory and scientific/technical ... post-approval, including biologic upstream and downstream processes, analytical methods, and drug / device combination products. + Comprehensive knowledge and… more
    Otsuka America Pharmaceutical Inc. (04/26/25)
    - Related Jobs
  • QC - Environmental Monitoring Technician (Night…

    Lilly (Concord, NC)
    …up. The Quality Control Laboratory assures patients worldwide receive safe and efficacious drug and drug / device combination products through effective ... Lilly is designing and building a new state of the art Parenteral, Device , and Packaging Assembly Facility in Concord, North Carolina. This is an exciting… more
    Lilly (04/25/25)
    - Related Jobs
  • Parkinson's Account Executive

    AbbVie (Raleigh, NC)
    …(AE) is responsible for maximizing business opportunities with approved on-market products ( drug device combination ) for the Parkinson's Franchise. The ... credentialing requirements may include, but not limited to, background checks, drug screens, and proof of immunization/vaccination for various diseases. + Represent… more
    AbbVie (05/13/25)
    - Related Jobs
  • Associate Director, Engineering - Medical…

    Merck (Wilson, NC)
    …Wilson Packaging Technical Operations Team. This role will serve as the primary medical device and combination product (MDCP) point of contact for the site ... implementation and robust application at the site. Experience in design controls, device risk management, medical device , combination products, prefilled… more
    Merck (05/21/25)
    - Related Jobs
  • Global Patient Safety Affiliate, Alliance,…

    United Therapeutics (Research Triangle Park, NC)
    …globally and their operational implications for a wide range of product types ( drug , combination , device reporting obligations) and relationships (partner, ... to business challenges and fosters innovation + Working knowledge of drug development processes and activities + Basic analytical thinking; diagnoses complex… more
    United Therapeutics (05/17/25)
    - Related Jobs
  • QA Floor Support Supervisor (Day Shift)…

    Lilly (Durham, NC)
    …Supervisor provides support and QA oversight to night shift GMP operations in the Device Assembly and Packaging (DAP) area. The QA Floor Supervisor works along with ... the site Quality culture. + Ensures regular presence in device assembly and packaging areas to monitor GMP programs...to work overtime, as requested + Previous work with combination products or devices with experience with US/EU regulations… more
    Lilly (04/19/25)
    - Related Jobs
  • Quality Assurance Associate - Device

    Lilly (Durham, NC)
    …life better for people around the world. The Quality Assurance Associate - Device Assembly & Packaging team provides daily oversight, assistance, and guidance to ... operations and support personnel on quality matters. + Ensure regular presence in device assembly and packaging areas to monitor GMP programs, and quality systems. +… more
    Lilly (04/15/25)
    - Related Jobs
  • Software Test (Manual) Engineer (Medical…

    Fujifilm (Durham, NC)
    …results in a timely manner. + Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 ... will be a member of the Sustaining Development Team. They would work on a combination patches and hotfixes to support our product suite. The test engineer will do… more
    Fujifilm (05/21/25)
    - Related Jobs
  • Associate Director, External Manufacturing…

    Merck (Durham, NC)
    …Skills: . **Manufacturing** - Injection Molding and Automated Assembly of Medical Device Components. Final Assembly and Packaging of Combination Products. ... seeking a dynamic and versatile leader for External Manufacturing Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate… more
    Merck (05/19/25)
    - Related Jobs
  • Transportation Worker II - Traffic

    NC Department of Transportation (Chatham County, NC)
    …street sweeper, tandem dump truck, tractor "A" boom mower, truck w/aerial device ) Additional Expectations: The selected candidate must be able to legally operate ... within 360 days of the date of hire. Pre-employment drug testing is required for this position. As a...job postings say you can qualify by an "equivalent combination of education and experience." If that language appears… more
    NC Department of Transportation (05/24/25)
    - Related Jobs