Career Category

Job Description

Amgen is a leading human therapeutics company in the biotechnology industry.  For more than 35 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine.  As a Fortune 500 company serving millions of patients, Amgen is an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. 

Amgen is searching for a Manager for the Submission Process, Planning, and Management (SPPM) team within Global CMC, Devices, & Biosimilar Regulatory Affairs.  The mission of SPPM is to support productivity across the organization and stakeholders by: 

• Driving continuous improvement of processes and tools

• Ensuring awareness of processes across the organization; and

• Shaping the training strategy across the organization

The Manager in SPPM will be responsible for developing, maintaining, improving, and driving consistency across the practices and procedures related to CMC processes.  

Job responsibilities of the SPPM Manager include:

• Manage the new hire onboarding program

• Facilitate communication across Global CMC, Devices, & Biosimilar Regulatory Affairs to ensure process robustness and awareness

• Drive consistency across Global CMC, Devices, & Biosimilar Regulatory Affairs

• Develop and maintain training materials Global CMC, Devices, & Biosimilar Regulatory Affairs

• Train staff on select departmental processes and procedures 

• Ensure consistent use of processes and tools across department

• Continuous improvement of templates for presentations, timelines, trackers, and other tools

• Liaise with functions in GRAAS and Operations to ensure alignment 

• Participate in cross-functional special project teams

 
Basic Qualifications:

• Master’s degree OR

• Bachelor’s degree and 2 years of Pharmaceutical/Biotech and/or Healthcare and/or Med Device and/or

• Scientific experience OR

• Associate’s degree and 6 years of Pharmaceutical/Biotech and/or Healthcare and/or Med Device and/or

• Scientific experience OR

• High school diploma / GED and 8 years of Pharmaceutical/Biotech and/or Healthcare and/or Med Device and/or Scientific experience

Preferred Qualifications:

• BS degree in Life Science

• Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development 

• Regulatory CMC specific knowledge and experience 

• Mature project management and organizational skills 

• Strong and effective oral and written communication skills