Career Category

Job Description

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 AR5 team, focused on operational readiness and start-up.

Days- shift A

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 7am-7pm 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.

Responsibilities:

·       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.

Basic Qualifications:

·       Master’s degree OR

·       Bachelor’s degree and 2 years of Manufacturing or Operations experience OR

·       Associate’s degree and 6 years of Manufacturing or Operations experience OR 

·       High school diploma / GED and 8 years of Manufacturing or Operations experience

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

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.