Sr. Associate Manufacturing
Amgen Contract Manufacturing (ACM) is a strategic dimension of Amgen's manufacturing network leveraged to enhance operational competitiveness and ensure uninterrupted global supply of medicines to patients. ACM manages a continually changing combination of CMO sites and site/product combinations located all around the globe. This is a unique opportunity to actively engage with Amgen's internal operations in a holistic way while being on the forefront of industry trends and cutting-edge technologies through our external parties. The Sr. Associate Manufacturing role is a supportive internal Amgen role that uniquely will work with Amgen and external supplier teams to ensure the external Amgen Manufacturing network delivers quality supply of our vital medicines on time. The role will have but is not limited to the following responsibilities:
Manufacturing operations: Via cross functional team engagement, collect and enter data in budget spreadsheets; routing/monitoring/tracking inputs to contracts, confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc. Own NC Class I records, CAPA, and change control records.
Site performance monitoring: Facilitate collection, entry, and tracking data for site performance metrics; maintain/update list of improvement opportunities at contract sites; daily duties will include running appropriate internal meetings and issuing meeting minutes, analysis of data and metrics, improving tools used by the Work Center Teams (WCT), issuing purchase requests, completing goods receipts, and active participation in WCT internal meetings.
Project Management and Technology transfers: Track, follow up and drive action on activities in assigned projects. Track timeline and coordinate transfer team activities to achieve seamless product transfer to the contract site(s); participate in risk management activities as part of transfer; identify and escalate issues to the right level.
Bachelor's degree and 2 years of Biotech/Pharma experience
Associate's degree and 6 years of Biotech/Pharma experienc
High school diploma / GED and 8 years of Biotech/Pharma 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.