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 Specialist Manufacturing role is an 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, 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: Facilitate collection, entry, tracking and reporting of 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 Work Center Teams (WCT), oversight and reporting of procurement/payment of invoices, and active participation in WCT meetings with the contract site as well as internal site team.
Project Management and Technology transfers: Follow-up, track and drive completion of 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.
Bachelor's degree and 2 years of Biotech/Pharma experience
Associate's degree and 6 years of Biotech/Pharma experience
High school diploma / GED and 8 years of Biotech/Pharma experience
- Bachelor's in Engineering, or Science-related field
- 5 years of experience in protein, API, DS, DP, or packaging manufacturing environment
- 5 years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles
- 2 years of project management experience leading multi-functional and/or multi-location team
- 1 years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products
- Demonstrated matrix management and influencing skills.
- Manufacturing and cGMP knowledge / experience.
- Demonstrated negotiation skills.
- Operational Excellence proficiency and ability to drive continuous improvement.
- Financial/budgeting knowledge and business acumen.
- Proficient project management skills.
- Problem-solving and critical thinking.
- Understanding of contractual requirements.
- Technical writing and multi-level communication skills.
- Demonstrated ability to lead effectively in collaborative/team environment.
- Demonstrated ability to take initiative, drive action, and work under minimum supervision.