Amgen Sr. Associate - Contract Manufacturing, Work Cell in Cambridge, Massachusetts
Manufacturing operations: 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: Enter 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 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 experience
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 competencies of lower GCF levels.
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.
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.