Career Category

Job Description

• Quality Professional with background and experience in commercial production of Biological drug substance to oversee night shift operations.
• Conduct Quality Assurance activities related to quality floor support for solution and equipment prepartation, cell culture and product purification & Drug Substance Filling operations.
• Support of electronic batch record review and approval, change control, investigations and product release
• Work in a cross functional team with Process Development, Manufacturing, Supply Chain, Engineering and Facilities to ensure product quality and market supply
• Role may include participation in new product introductions, additional equipment, installation commissioning, qualification.
• Support continuous improvent initiatives

Education / Licenses

• Degree in Chemistry, Chemical Engineering Science or related technological field
• Doctorate degree & 2 years of directly related experience OR
• Master’s degree & 2 years of directly related experience OR
• Bachelor’s degree & 5 years of directly related experience

Relevant Experience

• 4-6+ years of relevant work experience in the commercial manufacturing environment within the pharmaceutical industry

Competencies / Skills

• Must have experience and understanding of GMP pharmaceutical production, biological drug substance experiance and operation preferred
• Experience with batch record review, and quality record support
• Experience in pharmaceutical equipment operation, design and control including GMP change control
• Experience in providing floor support, troubleshooting unit operations, and resolving and documenting investigations to support cGMP production
• Understanding of equipment log review and continuous monitoring requirements
• Good communication skills (technical writing and verbal communication/presentation)
• Interacts effectively with variety of communication and working styles
• Experience with regulatory audits and inspections
• Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality

Additonal Requirements

• Work on shift schedules will be required