Manufacturing Manager Site Lead ACDM
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Career Category
ManufacturingJob 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:
- Bachelors 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.
Required Experience:
Manager
Key Skills
- Lean Manufacturing
- Six Sigma
- Continuous Improvement
- ISO 9001
- Lean Six Sigma
- Management Experience
- Manufacturing & Controls
- 5S
- Manufacturing Management
- Kaizen
- Chemistry
- Manufacturing
About Company
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the ... View more
