Description
Job Description
**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.
