Drug Substance Manufacturing Specialist
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 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