Amgen Contract Manufacturing (ACM) provides a strategic dimension to Amgen’s manufacturing network to enhance operational competitiveness and ensure uninterrupted global supply of medicines to our patients. In order to continue to provide the supplemental capacity to the Amgen manufacturing network, it is increasingly important that ACM establish consistent, robust processes and systems to ensure quality and supply reliability with our external contract manufacturing network while closely partnering with our internal networks as well. Amgen is searching for a Manufacturing Associate for our Contract Manufacturing Business Operations and Strategy team. This role will report to the Director of Contract Manufacturing and will be based on main corporate campus in Thousand Oaks, CA.
ACM is seeking a highly motivated individual to support the ACM Operating Model as well as execute consistent robust processes and systems to ensure quality and supply reliability with our external contract manufacturing network. Along with key business partners (Finance, Operations Strategic Planning and Risk, External Supply Quality, Process Development and Manufacturing) this individual will be responsible to support the following activities:
+ Manufacturing operations: Maintain ACM database, SharePoint site, Box accounts, and others to ensure completion and accuracy of all information accessed by the team members. Secure the access controls to the information. Conduit to all the ACM requests for information or report outs. Assist on coordination of business operating reviews and internal facing forums. Support the consolidation of report for ACM.
+ Site performance monitoring: Facilitate and maintain up to date the SQDIP board. Own the training and SEE metrics for ACM and follow up with team members to ensure compliance.
+ Project Management, Site Selection and Technology transfers: Administer the strategic files, ACM calendars, Site Selection WCT and Tech Transfer WCT. Provide regular reports, dashboards and presentations that clearly summarize results and implications/recommendations to key stakeholders to inform decision making. Support development and implementation of new processes and procedures to standardize, simplify, and measure business processes within Amgen Contract Manufacturing
Associate’s degree and 4 years of Manufacturing & Operations related experience
High School diploma/GED and 6 years of Manufacturing & Operations related experience
+ Bachelor’s in Business Administration, Engineering, or Science-related field
+ 2+ years of experience in protein, small molecules, API, DS, DP, or packaging manufacturing environment
+ 2+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles
+ 1+ years of project management experience leading multi-functional and/or multi-location team
+ Demonstrated project management skills.
+ Proficient in information systems.
+ Problem-solving and critical thinking.
+ Understanding of contractual requirements.
+ Technical writing and multi-level communication skills.
+ Basic financial acumen.
+ Strong quantitative and analytical skills.
+ Demonstrated ability to work effectively in collaborative/team environment.
+ Demonstrated ability to take initiative and action.
+ Ability to work in a fast paced, dynamic environment.
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.