Senior Manufacturing Associate II-Upstream

Bachelor’s degree in a related scientific or engineering discipline with 4-6 years’ experience in related GMP manufacturing operations; or high school degree with 7-10 years’ experience in related GMP manufacturing operations for Sr. Manufacturing Associate I
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 for Sr. Manufacturing Associate II
Excellent written and verbal communication skills are required
Energetic, motivated, and dynamic individual

Perform upstream or downstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products
Follow written, approved procedures and forms to ensure all work is conducted ‘Right First Time’ (RFT) following Good Manufacturing Practice (GMP)
Work individually or on teams to author standard operating procedures (SOPs) or Master Batch Records (MBRs)
Write corrective and preventive actions (CAPAs)
Specify, commission, and qualify new equipment
Execute daily tasks and maintain strict accordance with manufacturing records, SOPs, and GMP with minimal supervision
Communicate effectively with the manufacturing supervisor and support groups
Work cross-functionally with QA, MS&T, facilities, engineering, supply chain, IT, AFS, and other key departments to ensure successful manufacturing operations
Review the manufacturing schedule, executed manufacturing documentation, and ERP orders to ensure compliant operations and schedule adherence

Basic knowledge of upstream (cell culture or fermentation) or downstream (purification and bulk filling) unit operations is preferred
Experience in single-use platform technology is preferred