Job Description
HOW MIGHT YOU DEFY IMAGINATION? You've earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you've worked hard to acquire and the passion you already have. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role. Sr. Manager - Contract Development and Manufacturing Support Team Lead (EU) Live Lets do this - Lets change the world! - In this important role, you will lead the manufacturing support team in providing information insight and data analysis, drive execution of manufacturing activities to ensure Amgen Contract Development & Manufacturing (ACDM) is successful. The Sr. Manager ACDM Support Team Lead will be responsible for overseeing the team of highly motivated and driven professionals and leading and directing them as they carry out the following responsibilities: Manufacturing operations: Ensure accuracy and completion of data entries and/or tasks for budget development, monitoring, and reporting; inputs to contracts, confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc. Own NC Class II/III records, CAPA, CAPA EV, and more complex change control records. Site performance monitoring: Report contract site performance metrics to site lead; identify improvement opportunities for site performance; daily duties will include coordination, issuance, and review of meeting minutes, conclusions from analysis of data and metrics, continuous improvement and standardization of performance tools used by the teams, oversight and reporting of procurement/payment of invoices, and active participation in team meetings with the contract site as well as internal site team. Project Management and Technology transfers: Follow-up and track activities in a department-wide project from conception to implementation and close-out. Manage timeline and highlight risks of transfer team activities; coordinate risk management activities as part of transfer; provide escalation to the right level. Site Lead Support- In this position, you might occasionally need to assume extra responsibilities for Site Lead activities and lead as well as manage more complicated quality related issues when necessary. Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic manufacturing professional we seek has the following qualifications: Preferred Qualifications: Bachelor's in Business Administration, Engineering or Science 8+ years proven experience in protein, Active Pharmaceutical Ingredients, Drug Substance, Drug Product, or packaging manufacturing environment 8+ years working knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles 5+ years demonstrated in a people leadership and team management role Self-starter with a high-level of comfort with ambiguity and complexity and the ability to multi-task while consistently delivering quality results Experienced team leader of cross-functional and matrixed teams including effective writing, presentation, and interpersonal skills to address a broad scope of audiences Thrive What you can expect of us As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being. Vast opportunities to learn and move up and across our global organization. Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act. Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.