Senior Manufacturing Associate I/II – Night Shift

Senior Manufacturing Associate I/II – Night Shift

Requirements

• Senior Manufacturing Associate I: Bachelor’s degree in a related scientific or engineering discipline with 4-6 years’ experience in related GMP manufacturing operations; or high school diploma with 7-10 years’ experience in related GMP manufacturing operations
• Senior Manufacturing Associate II: Bachelor’s degree in a related scientific or engineering discipline with 5+ years’ experience in related GMP manufacturing operations; or high school degree with 10+ years’ experience in related GMP manufacturing operations
• Excellent written and verbal communication skills are required

Responsibilities

• Manufacture bulk intermediates and drug substances per manufacturing batch records and in compliance with quality standards, company policies, and current regulations
• Perform operations in a cleanroom environment, applying controls to ensure aseptic processing including gowning and cleaning procedures
• Document each task involving manufacturing records and logbooks following GDP at the time of execution
• Utilize and perform maintenance on equipment per applicable SOP
• Ensure all materials are issued and accounted for during the execution of a record
• Demonstrate, apply, and ensure understanding of cGMP and how it applies to specific tasks and responsibilities
• Participate and be accountable for workplace organization (5S)
• Provide direction/guidance to Manufacturing Associates. Help supervisor to distribute the workload and ensure others understand the requirements of their tasks.

Preferred Qualifications

• Knowledge of upstream unit operations preferred
• Experience in single-use technology preferred