Senior Associate Manufacturing - Bulk Drug Substance Downstream

• Execute on-the-floor operations within manufacturing in accordance with cGMP practices
• Complete work in accordance with established cGMP procedures and policies with strict adherence to safety and compliance
• Initiate quality non-conformance (NC) reports
• Assure proper gowning and aseptic techniques are always followed
• Perform hands-on downstream biotech operations 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
• Complete washroom activities
• Initiate and own manufacturing related process deviations
• Identify, recommend, and implement innovative process improvements and optimizations
• Assist in the review of documentation for assigned functions
• Collaborate as part of a cross-functional team in completing production activities
• Responsible for recognizing and elevating problems during daily operations
• Participate in the implementation of programs and CAPAs
• Drive safety in all operations
• Maintain an organized, clean, and workable space
• Draft and revise documents
• Interact with management as an advisor in planning and in escalating potential concerns

High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience OR Associate’s Degree + 2 years manufacturing and/or other regulated environment experience OR Bachelor’s Degree + 6 months manufacturing and/or other regulated environment experience OR 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