Summary
Site lead for Contract Manufacturing Organizations (CMOs).
Single point of accountability and interface between Amgen and assigned external partners.
Responsibilities
Manufacturing operations
: Develop and lead robust business processes, maintain reliable relationships with contract site management; assess industry trends, internal network, and technology advancements as tools to improve contract site performance.
Manage budget development, monitoring, and reporting; create and manage contracts - confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc.
; monitor and improve financials with CMO; actively manage and communicate forecasts to the sites and manage capacity planning.
Drive operational excellence and champion change.
Site performance monitoring
: Manage contract site performance using lean tools and PDCA, lead site operating review meetings; drive improvements at contract sites; sustain and improve the overall health of the business, and lead communication/relationship with the contract site as well as internal management.
Project Management and Technology transfer
: Lead a department-wide project from conception to implementation and close-out.
Present to and obtain buy-in for value proposition of such projects to senior management.
Provide oversight of all planning and coordination of product transfer activities to the contract site(s); develop, present, and obtain approval of budget, timeline and ensure execution of transfer team activities to achieve seamless product transfer to the contract site(s); ensure risk management initiatives are taking place as per RM plan; lead site issue management and resolution; provide issue escalation to executive management.
Qualifications
Minimum requirements (as per standard)
Preferred Requirements
Bachelor's in Business Administration, 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 experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products
1+ years of project management experience leading multi-functional and multi-location team
1+ years of experience across ACM or CMQ
Ability to travel +/- 20% of time (domestic and international)
Competencies
Demonstrated competencies of lower GCF levels.
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.
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