Sr Associate Mfg - Nights
About The Position
Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Requirements
- High school diploma / GED and 4 years of Manufacturing or Operations experience OR
- Associate’s degree and 2 years of Manufacturing or Operations experience OR
- Bachelor’s degree and 6 months of Manufacturing or Operations experience OR
- Master’s degree
Nice To Haves
- Knowledge of small-scale bioreactors, wave bioreactors, and aseptic processing.
- CFR and Regulatory knowledge
- Mechanical ability/expertise
- Knowledge of WIP lab equipment and computers, with LIMS access
- Basic statistical mathematical skills
- Ability to interpret and apply GMP knowledge
- Understanding of analytical methods for the manufacturing area
- Ability to demonstrate technical writing capability with Trackwise access
- Able to demonstrate project management skills and presentation skills
- Independently collaborate with outside resources
- Ability to understand, apply and evaluate basic chemistry, biology and physical principles
- Basic troubleshooting skills on bioreactors
- Experience with Delta V, RD’s
- Experience with lab equipment/testing
Responsibilities
- Perform operations in the Manufacturing area, specifically Inoc/Seeds, according to Standard Operating Procedures (SOPs).
- Perform and monitor critical processes.
- Execute routine validation protocols.
- Draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports.
- Perform basic troubleshooting and assist in the review of documentation for assigned functions.
- Participate on cross-functional teams and represent the Inoc/Seeds group.
- Own NC/CAPA’s and Change Control records.
- Identify, recommend, and implement improvements related to routine function.
- Lead manufacturing operations on the production floor.
- Ensure all safety and compliance procedures are followed at all times.
- Participate in the development, implementation, and issue resolution associated with process equipment Commissioning, Qualification, and Validation.
- Provide troubleshooting, technical support, and resolution of equipment, automation, and process issues on the manufacturing floor.
- Write, revise, and own controlled documentation (SOPs, Manufacturing Procedures (MPs), Forms, Technical Reports, etc.).
- Serve as SME for functional area operations.
- Provide training to manufacturing staff on process and equipment.
- Own deviations and Corrective and Preventive Actions (CAPA).
- Champion Lean Transformation and OE initiatives; facilitate the drive towards continuous improvement in all Manufacturing areas.
- Collaborate with Quality, Engineering, Process Development, Validation, and Operations to resolve manufacturing events in a timely manner.
- Assure appropriate escalation to different levels of management when personnel and environmental safety, equipment functionality, product supply, or quality are at risk.
- Collaborate with Quality, Manufacturing Managers, Plant Engineering, Process Development, and Regulatory Compliance staff in multi-functional teams.
- Participate in the design, development, and implementation of processes in support of the manufacturing floor.
Benefits
- A 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
- Stock-based long-term incentives
- Award-winning time-off plans
- 15% shift differential
- Premium pay for any Sundays worked
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
