Senior Associate Manufacturing - Bulk Drug Substance Downstream - Days
About The Position
The Senior Associate Downstream Manufacturing works in the manufacturing organization at Amgen North Carolina, executing on-the-floor operations in Manufacturing Services areas to manufacture cGMP drug substance. The role performs work under general direction and follows established cGMP procedures and policies, with strict attention to safety and compliance. The initial schedule is Monday through Friday, eight-hour days, and may include work from home; it may transition to a 12-hour day or night shift as business needs dictate. The position involves operating, preparing, cleaning, and monitoring manufacturing equipment and assigned areas; running critical process tasks; performing in-process sampling; operating analytical equipment; and completing process documentation. The Senior Associate also supports documentation review, process improvements, CAPA implementation, cross-functional production activities, safety, and administrative document drafting and revision.
Requirements
- High school diploma or GED and 4 years of manufacturing and/or other regulated-environment experience; or an associate degree and 2 years of such experience; or a bachelor's degree and 6 months of such experience; or a master's degree.
- Follow cGMP procedures, safety requirements, and compliance practices.
- Communicate effectively in verbal and written technical contexts.
Nice To Haves
- Completion of the NC BioWorks Certification Program.
- Experience in biotechnology or pharmaceutical plant startup.
- Knowledge of and process experience in a cGMP manufacturing facility or other highly regulated environment.
- Strong understanding of solution preparation, equipment preparation, and inventory control operations.
- Proficiency with Microsoft Office and knowledge of electronic systems such as EBR/MES, Delta V, and electronic quality systems.
Responsibilities
- Complete work in accordance with cGMP procedures and policies, including SOPs, manufacturing procedures, job hazard analyses, and applicable regulations, while adhering strictly to safety and compliance requirements.
- Initiate deviation reports and interact with regulatory agencies as needed and guided.
- Ensure proper gowning and aseptic techniques are followed.
- Set up, clean, sanitize, and monitor equipment and assigned manufacturing areas.
- Run and monitor critical process tasks according to assigned procedures.
- Perform in-process sampling, operate analytical equipment, and complete electronic batch record documentation.
- Complete washroom activities, including cleaning equipment used in production at small and large scales.
- Identify, recommend, and implement process improvements and optimizations for routine functions.
- Assist with review of documentation for assigned functions, including equipment logs and electronic batch records.
- Collaborate with cross-functional teams, including QA/QC, Facilities & Engineering, PPIC, Manufacturing, Process Development, and Regulatory, to complete production activities.
- Recognize and escalate problems during daily operations.
- Participate in implementing programs and CAPAs with a focus on continuous improvement.
- Promote safety in all operations and assist the manager in escalating concerns.
- Maintain an organized, clean, and workable space.
- Draft and revise SOPs, technical reports, and manufacturing procedures.
- Advise management in planning and escalate potential schedule or process concerns.
Benefits
- Health and welfare plans for employees and eligible dependents.
- Financial plans with opportunities to save for retirement or other goals.
- Work/life balance and career development opportunities.
- 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.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
High school or GED
