Regulatory Affairs CMC Manager (SPPM)

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:

• Masters degree OR

• Bachelors degree and 2 years of Pharmaceutical/Biotech and/or Healthcare and/or Med Device and/or

• Scientific experience OR

• Associates 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

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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Amgen requires all staff in the United States, Puerto Rico and Canada 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.