Career CategoryManufacturing
Job DescriptionSenior Associate Manufacturing - Bulk Drug Substance Downstream - DaysWhat you will doLet's do this. Let's change the world. In this dynamic role, you will be a Senior Associate in the manufacturing organization at Amgen North Carolina (ANC). The essential position, which supports our
critical 24/7 manufacturing operations, works a 12-hour 2-2-3 schedule from 5:45am to 6:15pm. Associates will be executing operations on the floor in our downstream area and will be responsible for the manufacturing of cGMP (Current Good Manufacturing Practices) drug substances.
With general direction, the Senior Associate is responsible for executing on-the-floor operations within manufacturing in accordance with cGMP practices. As Amgen relies upon the regular attendance of staff members to meet legitimate business needs, staff must be able to work assigned 12-hour shift, including during inclement weather, some holidays and requested overtime in support of our 24/7 operations.
Compliance:
- 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
Process/Equipment/Facilities:
- 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
Administrative:
- 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
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The hard-working professional we seek is a team player with these qualifications.
Basic Qualifications:- 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
Preferred Qualifications:- 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
What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now and make a lasting impact with the Amgen team!careers.amgen.comSalary Range86,048.05USD -116,417.95 USD
