Drug Substance Manufacturing Specialist

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 efficiency and compliance
• Provide technical support of GMP manufacturing operations and staff.
  • Author, revise, and review GMP supporting documentation (SOP’s, Batch Records, Forms, etc.)
• Facilitate risk assessments and other cross-functional meetings and teams
• 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 APImanufacturing
• 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

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 efficiency and compliance
• Provide technical support of GMP manufacturing operations and staff.
  • Author, revise, and review GMP supporting documentation (SOP’s, Batch Records, Forms, etc.)
• Facilitate risk assessments and other cross-functional meetings and teams
• 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 APImanufacturing
• 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