24 days old

Regulatory Affairs Manager - CMC Site

Amgen
Thousand Oaks, CA 91360
  • Job Code
    114879553
Amgen

Job ID: R-84413
Location: Thousand Oaks, CA, US 91360

Amgen's CMC (Chemistry, Manufacturing and Controls) Site Manufacturing group is seeking a Regulatory Affairs Manager for our Thousand Oaks, CA headquarters campus.

The Regulatory Affairs CMC Site Team is responsible for input to the development and implementation of CMC regulatory strategies and activities for products manufactured at or planned for the specific site. The CMC site team interfaces with the site (R&D and operations authors) coordinate preparation of regulatory filings, identification of issues and factors that may implicate a regulatory strategy or activity. The CMC site team are members of CMC product teams. The CMC Site team is also responsible for coordination of site-specific change control regulatory assessments with input from the CMC Product teams and the CMC Region representative. The CMC site team is the key RA CMC representative on product deviation investigation teams.

This role is responsible for:
  • Strategy and execution of the site-specific aspects of the preparation of CMC post-market supplements
  • Facility registrations
  • Annual reports of minor changes for specific products
  • Will c ontribute to site inspections
  • A cts as key RA CMC representative on product deviation investigation teams
  • Participates in site change control teams


Basic Qualifications:

Doctorate degree and 2 years of CMC specific regulatory knowledge and experience
OR
Master's degree and 6 years of CMC specific regulatory knowledge and experience
OR
Bachelor's degree and 8 years of CMC specific regulatory knowledge and experience
OR
Associates degree and 10 years of CMC specific regulatory knowledge and experience
OR
High school diploma / GED and 12 years of CMC specific regulatory knowledge and experience

Preferred Qualifications:
  • 6+ years' experience in biological and/or chemical synthesis manufacturing, testing (QC/QA or clinical), or distribution in the Pharmaceutical/Biotech industry
  • Regulatory CMC experience
  • Ability to develop solutions to technical and organizational issues in order to improve performance and productivity
  • Able to work independently and proactively
  • Strong computer skills, including word processing, database document repository and project management software
  • Able to influence vertically and across functional boundaries
  • Strong team player with a commitment to customer service


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.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

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.

PI114879553

<b>Amgen</b><br/><br/><b>Job ID: </b>R-84413<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Amgen's CMC (Chemistry, Manufacturing and Controls) Site Manufacturing group is seeking a Regulatory Affairs Manager for our Thousand Oaks, CA headquarters campus.<br><br>The Regulatory Affairs CMC Site Team is responsible for input to the development and implementation of CMC regulatory strategies and activities for products manufactured at or planned for the specific site. The CMC site team interfaces with the site (R&D and operations authors) coordinate preparation of regulatory filings, identification of issues and factors that may implicate a regulatory strategy or activity. The CMC site team are members of CMC product teams. The CMC Site team is also responsible for coordination of site-specific change control regulatory assessments with input from the CMC Product teams and the CMC Region representative. The CMC site team is the key RA CMC representative on product deviation investigation teams.<br><br>This role is responsible for:<br><ul><li>Strategy and execution of the site-specific aspects of the preparation of CMC post-market supplements </li><li> Facility registrations </li><li> Annual reports of minor changes for specific products </li><li>Will c ontribute to site inspections </li><li> A cts as key RA CMC representative on product deviation investigation teams</li><li>Participates in site change control teams</li></ul><br><br><b>Basic Qualifications:</b><br><br>Doctorate degree and 2 years of CMC specific regulatory knowledge and experience<br>OR<br>Master's degree and 6 years of CMC specific regulatory knowledge and experience<br>OR<br>Bachelor's degree and 8 years of CMC specific regulatory knowledge and experience<br>OR<br>Associates degree and 10 years of CMC specific regulatory knowledge and experience<br>OR<br>High school diploma / GED and 12 years of CMC specific regulatory knowledge and experience<br><br><b>Preferred Qualifications:</b><br><ul><li>6+ years' experience in biological and/or chemical synthesis manufacturing, testing (QC/QA or clinical), or distribution in the Pharmaceutical/Biotech industry</li><li>Regulatory CMC experience</li><li>Ability to develop solutions to technical and organizational issues in order to improve performance and productivity</li><li>Able to work independently and proactively</li><li>Strong computer skills, including word processing, database document repository and project management software</li><li>Able to influence vertically and across functional boundaries</li><li>Strong team player with a commitment to customer service</li></ul><br><br>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.<br><br>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.<br><br>Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.<br><br>Join Us <br> <br> 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. <br> <br> 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. <br> <br> 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. <br> <br> 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.<br/><br/> <img src="https://analytics.click2apply.net/v/E5deVbTDV22dhY5bsXman"> <p>PI114879553</p>

Categories

Posted: 2019-10-25 Expires: 2019-11-25

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Regulatory Affairs Manager - CMC Site

Amgen
Thousand Oaks, CA 91360

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast