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Senior Associate Manufacturing - Solutions Prep

West Greenwich, RI 02817
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Job ID: R-103305
Location: West Greenwich, RI, US 02817

Shift: C - Rotating Nights (7pm - 7am)

Under minimal supervision, the Senior Associate Manufacturing will perform operations in the Solutions Prep area per Standard Operating Procedures. Senior Associate will perform and monitor critical processes (Batching and transferring Medias and Buffers, WIP Lab operations, SIP and CIP), execute routine validation protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOPs, NC/CAPA, and technical reports. Senior Associate will provide technical leadership to the team per the direction of the Solutions Prep Manager as well as perform complex troubleshooting. Additionally, the Senior Associate may identify, recommend, and implement improvements related to routine functions and participate in Cross-functional teams while representing the Solutions Prep Department.

  • Lead manufacturing operations on the production floor.
  • Ensure all safety and compliance procedures are always followed.
  • Participate in development, execution, and issue resolution associated with process equipment Commissioning, Qualification and Validation.
  • Provide troubleshooting and technical support to resolve 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.

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
  • Purification, Cell Culture or Solutions Prep. Experience and experience troubleshooting critical processes
  • Strong understanding of Delta V, RDs and PI
  • Knowledge of WIP lab equipment
  • Proficient in LIMS, and MES
  • Ability to demonstrate technical writing capability with Trackwise access
  • Able to demonstrate project management and presentation skills
  • 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
  • Ability to understand, apply and evaluate basic chemistry, biology and physical principles
  • CFR and Regulatory knowledge

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.

Join Us

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.

Posted: 2020-08-25 Expires: 2020-09-25

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Senior Associate Manufacturing - Solutions Prep

West Greenwich, RI 02817

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