Senior AssociateManufacturing-Bulk Drug Substance Downstream-Nights

Senior Associate – Manufacturing – Bulk Drug Substance Downstream – Nights Amgen’s upcoming FleXBatch facility in North Carolina will combine disposable technologies with traditional stainless‑steel equipment to maximize flexibility and sustainability. This 12‑hour 2‑2‑3 schedule (5:45 pm–6:15 am) supports round‑the‑clock cGMP manufacturing of drug substances. What You Will Do You will execute on‑floor operations in the downstream area, ensuring compliance with cGMP, SOPs, and regulatory requirements. Your responsibilities include bookkeeping of batch records, sampling, equipment set‑up and cleaning, and continual process improvement. Compliance Complete work in accordance with cGMP procedures and policies, including SOPs, MPs, JHAs, and CFR. Initiate quality non‑conformance reports and aid in investigations. Interact with regulatory agencies as needed. Ensure proper gowning and aseptic techniques are followed. Process/Equipment/Facilities Understand downstream purification operations: column chromatography, TFF, viral filtration, and viral inactivation. Set up, operate, clean, sanitize, and monitor downstream equipment. Run and monitor critical process tasks per assigned procedures. Perform in‑process sampling, operate analytical equipment, and complete Electronic Batch Record documentation. Assist with equipment wash‑room activities and cleaning tasks. Identify, recommend, and implement process improvements. Collaborate across functions (QA/QC, Facilities & Engineering, PPIC, Mfg., PD, Regulatory) to complete production activities. Escalate problems and participate in CAPA implementation. Administrative Draft and revise SOPs, technical reports, and manufacturing procedures. Act as an advisor to management regarding scheduling and process concerns. What We Expect of You We seek a team player with reliable attendance and a commitment to quality and safety. The following qualifications are required: Basic Qualifications High School Diploma or GED plus 4 years manufacturing experience, or Associate’s Degree plus 2 years manufacturing experience, or Bachelor’s Degree plus 6 months manufacturing experience, or Master’s Degree. Preferred Qualifications Completion of the NCBioWorks Certification Program. Experience in biotechnology or pharmaceutical plant start‑up. Knowledge and process experience in a cGMP manufacturing facility. Understanding of downstream purification operations. Excellent verbal and written communication skills. Proficient Microsoft Office and experience with electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems. Benefits Comprehensive employee benefits package, including retirement and savings plans, medical, dental, vision, life, and disability insurance. Discretionary annual bonus program and long‑term stock‑based incentives. Time‑off plans and bi‑annual company shutdowns. Flexible work models, including remote work arrangements where possible. Compensation The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Equal Opportunity Employer Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. #J-18808-Ljbffr BioSpace