Senior Associate Manufacturing - Bulk Drug Substance Downstream - Nights

Amgen • Holly Springs, NC

5d • Onsite

About The Position

Amgen is seeking a Senior Associate in its manufacturing organization at Amgen North Carolina (ANC). This role supports critical 24/7 manufacturing operations, working a 12-hour 2-2-3 schedule from 5:45 PM to 6:15 AM. The associate will execute operations in the downstream area, responsible for the manufacturing of cGMP (Current Good Manufacturing Practices) drug substances. The Senior Associate will execute on-the-floor operations in accordance with cGMP practices, requiring regular attendance and the ability to work assigned 12-hour shifts, including during inclement weather, some holidays, and requested overtime to support 24/7 operations. This position is part of Amgen's newest and most advanced drug substance manufacturing plant, the FleX Batch facility, which combines disposable technologies with traditional stainless-steel equipment and integrates sustainability innovations.

Requirements

• 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

Nice To Haves

• Completion of NC BioWorks Certification Program
• Experience in biotechnology or 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

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.
• Understanding of downstream purification operation (Column Chromatography, TFF, Viral Filtration, Viral Inactivation).
• 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.

Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans and bi-annual company-wide shutdowns.
• Flexible work models, including remote work arrangements, where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed