Posted a month ago
Senior Associate Manufacturing - Bulk Drug Substance Downstream - Nights
AmgenSenior Associate Manufacturing - Bulk Drug Substance Downstream - Nights
Perks & benefits
Health InsuranceMedical Insurance
Requirements
High School Diploma + 4 years regulated experience, Associate's Degree + 2 years regulated experience, Bachelor's Degree + 6 months regulated experience, Master's Degree, Knowledge of downstream purification, Ability to work 12-hour night shifts
Skills
GMPChromatography
About the role
Responsibilities
- Execute on-the-floor downstream manufacturing operations for cGMP drug substances
- Perform hands-on biotech operations including Column Chromatography, TFF, Viral Filtration, and Viral Inactivation
- Complete process documentation using Electronic Batch Records (EBR) and maintain equipment logs
- Conduct in-process sampling and operate analytical equipment
- Ensure strict adherence to safety, gowning, and aseptic techniques
- Initiate quality non-conformance reports and manufacturing process deviations
- Collaborate with cross-functional teams including QA/QC, Engineering, and Process Development
- Support 24/7 operations by working a 12-hour night shift schedule (5:45pm to 6:15am) on a 2-2-3 rotation
Requirements
- High School Diploma/GED + 4 years of regulated manufacturing experience OR
- Associate’s Degree + 2 years of regulated manufacturing experience OR
- Bachelor’s Degree + 6 months of regulated manufacturing experience OR
- Master's Degree
- Knowledge of downstream purification processes
- Ability to work 12-hour night shifts, including holidays and overtime as needed
Preferred Qualifications
- Completion of NC BioWorks Certification Program
- Experience in biotechnology or pharmaceutical plant start-ups
- Proficiency with electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems
- Strong technical verbal and written communication skills
Benefits
- Comprehensive health, dental, and vision coverage
- Retirement and Savings Plan with company contributions
- Discretionary annual bonus program and stock-based long-term incentives
- Award-winning time-off plans and bi-annual company-wide shutdowns
About the Company
Amgen is a leading biotechnology company dedicated to unlocking the potential of biology to serve patients suffering from serious illnesses. By leveraging advanced human genetics and biologics manufacturing expertise, Amgen develops innovative human therapeutics to improve health outcomes for millions of people worldwide.
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Amgen · Holly Springs
