Senior AssociateManufacturing-Bulk Drug Substance Downstream-Nights

Responsibilities

• 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.
• Execute hands-on downstream biotech operations (Column Chromatography, Tangential Flow Filtration, Viral Filtration, Viral Inactivation, Column Packing among others).
• Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBR]).
• 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 across-functional team (i.e., QA/QC, F&E (Facilities & Engineering), PPIC, Mfg., PD (Process Development), Regulatory, etc.) in completing production activities.
• Recognize and elevate 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.

Qualifications

• High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience.
• Associates 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 (Preferred).

Preferred Qualifications

• Completion of NCBioWorks 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.