Senior Associate Manufacturing - Downstream - Nights

• Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR]) with strict adherence to safety and compliance
• Initiate quality non-conformance (NC) reports
• Interact with regulatory agencies as needed and guided
• Assure proper gowning and aseptic techniques are always followed
• Perform hands-on downstream biotech operations (Column Chromatography, Tangential Flow Filtration, Viral Filtration, Viral Inactivation, Column Packing among others) including set-up, operation, cleaning, sanitization, monitoring of equipment and assigned area
• Run and monitor critical process tasks per assigned procedures
• Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBR])
• Complete washroom activities: cleaning equipment, small to large scale, used in production activities
• Initiate and own manufacturing related process deviations
• Identify, recommend, and implement innovative process improvements and optimizations related to daily routine functions
• Assist in the review of documentation for assigned functions (i.e., equipment logs, EBRs)
• Collaborate as part of a cross-functional team (i.e., QA/QC, F&E (Facilities & Engineering), PPIC, Mfg., PD (Process Development), Regulatory, etc.) in completing production activities
• Responsible for recognizing and elevating problems during daily operations
• Participate in the implementation of programs and CAPAs (Corrective Action Preventive Action) with an eye toward continuous improvement
• Drive safety in all operations, and assist the manager in escalating concerns as needed
• Maintain an organized, clean, and workable space
• Draft and revise documents (SOPs, technical reports, and MPs)
• Interacts with management as an advisor in planning and in escalating potential concerns with the schedule and/or process

• High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience
• Associate’s Degree + 2 years manufacturing and/or other regulated environment experience
• Bachelor’s Degree + 6 months manufacturing and/or other regulated environment experience
• Master's Degree
• Completion of NC BioWorks Certification Program
• Experience in biotechnology or pharmaceutical plant start up
• Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment
• Understanding of downstream purification operation (Column Chromatography, TFF, Viral Filtration, Viral Inactivation)
• Excellent verbal and written communication (technical) skills
• Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems

• Completion of NC BioWorks Certification Program
• Experience in biotechnology or pharmaceutical plant start up
• Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment
• Understanding of downstream purification operation (Column Chromatography, TFF, Viral Filtration, Viral Inactivation)
• Excellent verbal and written communication (technical) skills
• Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards