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 continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness.
Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen is searching for a Senior Associate within the Regulatory Optimization of Tactical and Strategic Support (ROOTS2) group in RA CMC. The ROOTS2 team supports CMC submission execution for the Amgen products across phase of development, moiety and region.
The RA CMC Senior Associate will interface with the Amgen RA CMC global and regional teams, site regulatory, the biosimilars unit as well as the device team for specific strategies or activities that impact a product. The RA CMC Senior Associate will be responsible for varying levels of product support, including leading projects, based upon their experience level.
Additional job responsibilities of the RA CMC Senior Associate include:
- Contribute as a key member of the global regulatory CMC product team
- Interact with authors/reviewers and subject matter experts with respect to delivery of regulatory documents required for regulatory submissions
- Contribute to the organization and preparation of CMC investigational product amendments, post‑market supplements/variations, and new marketing applications
- Lead the organization and preparation of the CMC sections of global annual notifications to meet regulatory requirements
- Document and archive CMC submissions and related communications in the document management system
- Initiate and maintain CMC product timelines at the direction of product lead
- Interface with the regulatory operations team
- Train staff on select CMC procedures and systems
- Provide report status of activities and projects to teams and department
- 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
- Developed 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.