Career CategoryManufacturing
Job DescriptionAssociate Manufacturing - Downstream - Nights (Multiple Positions) Live What you will do Let's do this! Let's change the world! In this dynamic role, you will be an 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 5:45pm to 6:15am. Associates will be completing 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 Associate will support all floor operations 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.
Responsibilities will include...
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
- Assure proper gowning and aseptic techniques are always followed
Process/Equipment/Facilities:
- Perform hands-on downstream bio-tech operations (Column Chromatography, Tangential Flow Filtration among others) including set-up, 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 [EBRs])
- Complete washroom activities: cleaning equipment, small to large scale, used in production activities
- Initiate and own manufacturing related process deviations
- Identify and escalate issues and concerns regarding daily routine functions related to process and tasks; may engage with team on potential solutions
- Perform 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
- Maintain an organized, clean, and workable space
Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The hard-working professionals we seek are team players with these qualifications.
Basic Qualifications: - High School/GED + 2 years manufacturing and/or other regulated environment experience
Or
- Associate's Degree + 6 months manufacturing and/or other regulated environment experience
Or
Preferred Qualifications: - Completion of NC BioWorks Certification Program
- Experience in a regulated industry such as biotechnology or pharmaceutical
- Basic understanding and process experience in a cGMP manufacturing facility
- Excellent verbal and written communication
- Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems
- An ability to demonstrate desire and drive to learn and grow their understanding of operations and processes
Thrive What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
- 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, or for field sales representatives, a sales-based incentive plan
- 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
Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us.
careers.amgen.com Salary Range70,985.20USD -96,038.80 USD
