Drug Product Manufacturing Specialist Details

splintpharma - Remote

Employment Type : Full-Time

Responsibilities include but are not limited to:

  • Serve as a manufacturing technical SME on a cross functional special project
    • Acts as Manufacturing Record Owner of a subset of quality records, including Deviation, CAPA and Change Control
    • Drivethese quality records to successful closurein partnership with cross functional SMEs and Record Owners (i.e. Quality, Regulatory)
    • Conduct and document detailed investigations independently
    • Lead and support continuous improvements of manufacturing processes to enhance efficiencyand compliance
  • Provide technical support of GMP manufacturing operations and staff.
    • Author, revise, and review GMP supporting documentation (SOP’s, Batch Records, Forms, etc.)
  • Support internal and external audits and inspections as needed
  • Perform other duties as assigned

 

Minimum Requirements:

  • Bachelor's degree in engineering or life science
  • Minimum 3 years' experience in GMPbiologics and/or vaccine Drug Productmanufacturing
  • Demonstrates interpersonal, technical aptitude, and problem-solving skills
  • Knowledgeable in systematic root cause analysis methodologies and their application of these methodologies 
  • Knowledge and expertise in principles and practice of current Good Manufacturing Practices (cGMPs)
  • Excellent verbal, written, and interpersonal communication skills
  • Proficiency in Microsoft products, including Microsoft Office applications, Microsoft Teams, Microsoft SharePoint, PowerBI
  • Experience with Quality Management Systems & statistical analyses is preferred