Auto req 13873BR
Job Posting Title Manufacturing Specialist - NPI/Packaging
Career Category Operations
Employee Subgroup Salaried FT
Country (State/Region) United States - California
Location (City) Thousand Oaks
Amgen Job Description This role will work within the New Product Introduction group of Amgen’s ATO Fill and Packing Organization and will be a key process leader in the introduction of new products within the Packaging department.
The specialist will be a representative for ATO Packaging within the clinical commercialization program and serve as a key manufacturing operations liaison for new product introductions with an high degree of expected interaction with Quality, Planning, Engineering, Clinical Planning, Process Development, Global Operations teams, and other supportive and client groups.
Additional responsibilities will include routine interaction with key quality and manufacturing systems, as well as with Operational Excellence (OE) initiatives, and global networks.
Areas of scope and responsibilities include but are not limited to:
• Supporting/Leading New Product Introductions (NPIs)
• Ability to write, revise, and own manufacturing documentation (SOPs, Manufacturing Procedures, Device requirements (MPs), Forms)
• Owner/lead author for Non-Conformances (NC’s), Corrective and Preventive Actions (CAPA’s), and Change Controls records that occur in association with the new product introduction process.
• Work closely with Regulatory, Quality, and required accessors to manage change control processes and respond to regulatory questions and/or audit findings within the scope of the new product introductions
• Operational Excellence (OE) core team member who will champion OE initiatives, and facilitate the drive towards continuous improvement as it relates to new product introductions processes and shared opportunities with client and support groups
• Work closely with Quality, Engineering, Process Development, Validation, and Operations to resolve project management issues in a timely manner
• Assure appropriate escalation to various levels of management when timeline requirements for new product introduction are at risk or exceeded
• Collaborate with Quality, Mfg Managers, Plant Engineering, Process Development and Regulatory Compliance staff in cross-functional teams
• Apply advanced process, operational, scientific expertise, compliance knowledge and analytical and troubleshooting skills to support manufacturing operations
• Manage generation and presentation of key operating metrics for functional area
• Provide training to manufacturing staff in support of new product introduction where appropriate
Basic Qualifications • Doctorate degree
OR
• Master’s degree & 3 years of directly related experience
OR
• Bachelor’s degree & 5 years of directly related experience
OR
• Associate’s degree & 10 years of directly related experience
OR
• High school diploma / GED & 12 years of directly related experience
Preferred Qualifications Bachelor’s degree & 5 years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality)
• Project management experience
• Detailed technical understanding of packaging operations
• Experience participating in and leading cross-functional teams
• Experience in managing multiple, competing priorities in a fast-paced environment
• Strong technical writing and verbal presentation skills
• Ability to be flexible and manage change
• Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
• Ability to communicate/manage upwards to high level stake holders (Director and above)
• Highly detailed orientated
• Exceptional organizational skill
• Experience with a Current Good Manufacturing Practices (cGMP)
• Experience with change control and non-conformance management systems/processes
Preferred Qualifications:
• Extensive technical knowledge of drug product packaging, drug product delivery devices, and a broad understanding of related disciplinary areas
• Experience interacting with representatives of regulatory agencies
• Detailed technical understanding of packaging operations
• Strong experience with Microsoft Office suite - PowerPoint, Word, Outlook
• Advanced Microsoft Excel experience in the management/analysis of data; including use of Excel Pivot Tables and advanced Excel chart management (formula statements, etc)
• Strong experience with Microsoft SharePoint environment including the creation and management of Ninetex workflow
• Ability to organize, analyze, and interpret technical data through trend analysis, forecasting, modeling, etc.
• Understands the core functional business processes and their role in Amgen's commercialization program
