The Senior Associate Manufacturing is a hands-on role in one of the two manufacturing facilities on site at Amgen Rhode Island. Successful candidates will join the AR30 team, focused on operational readiness and start-up.
The on-boarding phase for this role will last 2 weeks, during which time successful incumbents will be on an administrative schedule (Monday through Friday, approximately 8am to 5pm). Following the on-boarding phase, the successful incumbent will be expected to join a shift team working a 12-hour shift. The shift pattern will be 7PM-7AM with a two-week rotation covering 7 days per week. The rotating shift offers several benefits, with an average of 14 days on shift per month with every other weekend off. In addition, any Sundays worked receive Premium pay.
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.
Lead manufacturing operations on the production floor.
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.
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
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.