Job Description:
HOW MIGHT YOU DEFY IMAGINATION?
You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Senior Associate Manufacturing – Nights
LIVE
WHAT YOU WILL DO
Let’s do this! Let’s change the world! In this vital role, you will be part of the team at Amgen's Rhode Island site in building 30, as part of the Upstream Operations team on D shift.
Under minimal supervision, the Senior Associate will perform and monitor critical processes, execute routine qualification and validation protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOPs, deviations/CAPAs, and technical reports. The Senior Associate will provide technical leadership to the team per the direction of the area manager as well as perform complex troubleshooting. Additionally, the Senior Associate may identify, recommend, and implement improvements related to routine functions and participate on cross-functional teams while representing their home department. This role is a key communication and technical interface between the GMP manufacturing teams in the plant and our partner organizations.
Responsibilities:
- Lead manufacturing operations on the production floor, according to GMP (Good Manufacturing Practices) standards.
- Ensure all safety and compliance procedures are followed at all times.
- Participate in the development, execution, 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 various 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 cross-functional teams.
- Participate in the design, development, and implementation of processes in support of the manufacturing floor.
In this role, you will be expected to work a 12-hour shift (7PM-7AM) on a rotating schedule (D Shift). This includes extra benefits such as RECEIVING AN ADDED 15% SHIFT DIFFERENTIAL, AND ALSO GETTING PREMIUM PAY FOR ANY SUNDAYS WORKED. The schedule during the initial on-boarding/training phase (2-6 weeks) will be administrative (Monday through Friday, approximately 8am to 5pm).
WIN
WHAT WE EXPECT OF YOU
We are all different, yet we all use our unique contributions to serve patients. The motivated professional we seek is a team-player with these qualifications.
BASIC QUALIFICATIONS:
- High School/GED and 4 years of manufacturing or operations work experience OR
- Associate’s Degree and 2 years of manufacturing or operations work experience OR
- Bachelor’s Degree and 6 months of manufacturing or operations work experience OR
- Master’s Degree
PREFERRED QUALIFICATIONS:
- Bachelor’s degree in Science or Engineering.
- Knowledge of cell culture operations and bioreactors or purification operations including aseptic processing.
- Experience operating single-use systems.
- Knowledge of DeltaV (for process control) and Windows-based software.
- CFR and Regulatory knowledge.
- Mechanical aptitude with ability and expertise.
- Ability to independently collaborate with outside resources.
- Basic statistical mathematical skills.
- Ability to interpret and apply GMP knowledge.
- Understanding of analytical methods and equipment for manufacturing area.
- Demonstrated technical writing capability.
- Ability to understand, apply, and evaluate basic chemistry, biology, and physical principles.
- Troubleshooting skills on process equipment.
- Ability to lead teams.
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.
This position will be paid on an hourly basis. The annualized base pay range for this opportunity in the U.S. is $80,270-$97,036.
In addition to the base salary, 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
