Senior Associate Manufacturing - Bulk Drug Substance Upstream - Days

Amgen•Holly Springs, NC

3d•Onsite

About The Position

Join Amgen’s Mission of Serving Patients. You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Requirements

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

Nice To Haves

Completion of NC BioWork Certificate Program
Experience in biotechnology or pharmaceutical plant start up
Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment
Basic understanding of Upstream operation (Vial Thaw, Inoculation/Cell Expansion, Single Use Bioreactor, Production Bioreactor, ATF, Harvest Centrifuge, Depth Filtration)
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 observations (Discrepancies, Deviations, Testing Results Analysis (TRA), etc.) as well as support or lead evaluations and investigations into quality observations
Interact with regulatory agencies as needed and guided
Assure proper gowning and aseptic techniques are always followed
Support operational readiness activities for facility expansion and startup
Execute manufacturing readiness tasks including equipment preparation, procedure execution, and process walkthroughs
Participate in commissioning, qualification, and startup activities as trained and assigned
Provide operational feedback during startup activities to support safe, compliant, and efficient manufacturing
Support readiness planning through execution of training, procedures, workflows, and operational practices for startup and ramp-up
Perform hands-on operations including set-up, cleaning, sanitization, monitoring of equipment of 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
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, ESPs)
Collaborate cross-functionally (i.e., QA/QC, F&E (Facilities & Engineering), PPIC (Production Planning and Inventory Control), 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