Amgen Sr. Associate Regulatory Affairs CMC in Thousand Oaks, California
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.
Amgen is searching for a Regulatory Affairs, Chemistry, Manufacturing and Controls Senior Associate (RA CMC) to work in their main corporate campus in Thousand Oaks, CA.
Regulatory Affairs, Chemistry, Manufacturing and Controls 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.
The RA CMC team generates the regulatory CMC strategy of the product/variation and provides feedback to the technical teams, including plans for execution of the strategy. The RA CMC Senior Associate will interface with the Amgen RA CMC leads, product teams, regional offices, and site teams 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 responsibilities of the RA CMC Senior Associate include:
Contribute to the organization and preparation of CMC investigational product amendments and post-market supplements, organization and preparation CMC sections of IND annual reports and annual reports of minor changes for specific products to meet the strategy defined by the global CMC team.
Document CMC submissions and related communications in InSight Manager for Registrations.
Utilize InSight Manager for Registrations (IMR); archiving documents in document management systems.
Initiate and maintain CMC product timelines at the direction of product lead.
Process regulatory assessments of change control requests.
Train staff on select CMC procedures and systems.
Interface with regulatory operations staff.
Contribute to CMC product teams: interacts with authors/reviewers with respect to delivery of documents required for regulatory submissions.
Provide report status of activities and projects to teams and department.
Participate in cross-functional special project teams.
Contribute to the design and content development of department training programs.
Bachelor's degree and 2 years of experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry
Associate's degree and 6 years of experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry
High school diploma / GED and 8 years of experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry
BS degree in Life Science
Regulatory CMC experience
Process Development experience
Quality Assurance, or Analytical development experience
CMC-specific regulatory knowledge & experience
Strong & effective oral and written communication skills
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.