Career Category

Job Description

• Provide data to support management evaluation of performance trends
• Provide subject matter expertise and on the floor support for area of responsibility/ownership
• Own quality records (change control, CAPA, deviations) and deliver to timelines
• Oversee Downstream process owner’s quality records
• Identify and autonomously implement continuous improvement opportunities
• Creation of solid business cases for improvement ideas
• Collaborate with Quality, Process Engineering, Regulatory, and Process Development to implement Buffer/Media Preparation, Cell Culture and/or Purification and drug substance filling processes and process improvements
• Support of front-line managers through on the floor presence
• Own and author critical standard operating procedures and supporting documentation/training.
• Lead and/or support root cause investigations related to performance trends and formal deviations
• Support of product reintroductions
• Develop, implement and assess solutions for complex problems
• Anticipate risk and builds contingencies to help mitigate impact
• Participate in regulatory audits

Basic Qualifications

• Doctorate Degree OR
• Master's Degree and 3 years of Manufacturing and Operations experience OR
• Bachelor's Degree and 5 years of Manufacturing and Operations experience OR
• Associate's degree and 10 years of Manufacturing and Operations experience OR
• High school diploma/GED and 12 years of Manufacturing and Operations experience AND
• Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications

• Single use technology experience
• Extensive experience defending approaches during regulatory audits
• Purification Experience
• Knowledge and experience within a cGMP or other highly regulated environment including a basic understanding of technical elements across engineering, biological or chemical processing
• Strong knowledge of cleaning and sterilization validation
• In depth experience with New Product Introduction and technology transfer
• Strong leadership and teambuilding skills (coaching, mentoring, counseling)
• Experience with Lean Principles and continuous improvement
• Experience with performance management including conflict resolution and performance reviews
• Analytical problem-solving skills
• Project Management skills
• Thorough understanding of regulatory requirements
• Ability to be flexible and manage change
• Excellent verbal and written communication (technical) skills
• Hands on experience facilitating problem solving and root cause investigations in a biotechnology environment
• Strong project management skills with ability to multi-task and function in a dynamic environment
• Excellent communication skills, drive, and sense of urgency
• Demonstrated ability to forge and maintain strong relationships within other functional areas
• Ability to recommend, judge, and make good decisions in complex situations
• Ability to tactfully and effectively negotiate and influence

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.