Specialist Manufacturing, New Product Introductions

Career Category Manufacturing Job Description HOW MIGHT YOU DEFY IMAGINATION? You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role. Specialist Manufacturing, New Product Introductions Live What you will do Let’s do this. Let’s change the world. In this vital role you will work as a Manufacturing Specialist supporting New Product Introductions (NPI) as part of the B20 NPI team within the Drug Product Supply organization in Amgen Thousand Oaks. This role serves as a product and process lead for New Process Introductions (NPI) into the manufacturing facility. The specialist will function as the site interface between the Product Delivery Teams (PDT’s), and B20 Senior Management. A high degree of interaction is required with key functional groups, Planning, Supply Chain, Quality, Engineering, Process Development, PDT teams and other supporting groups. Applying process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to ensure streamlined manufacturing operations are enabled. The Manufacturing Specialist will be primarily responsible for: Work with various NPI/TT support groups to develop, maintain, and implement the NPI/TT project plan. Specialist will function as the NPI lead and is accountable for NPI scope, schedule, resources, and risk management. Responsibilities include issue resolution in a timely manner and customer concern to various levels of management as appropriate. Assess and development of NPI/TT implementation plans in accordance to current business processes. Ensure the NPI is complete and sufficient for manufacturing implementation, coordination, and execution of required activities. This may include document preparation & revisions, change control management, manufacturing process modifications, equipment introductions/modifications, and supporting validation/engineering runs. Partnering with key functional groups to drive strategy definition for risk assessments, characterization, validation, regulatory, and filing achievements. Engage with network partners to develop process and technology strategies that achieves clinical/commercial development schedules while minimizing transfer risks. Lead NPI Product Team and associated meetings. Own and lead change controls as required by the NPI Project Team. Ensure compliance with project achievements such as conformance batch manufacturing, regulatory submissions, and product launches. Hold people accountable for delivery and behaviors within the Product team Review protocols for manufacturing activities. Documentation and approval of protocol deviations for manufacturing activities. Perform Change Control Assessments to determine impact to Manufacturing. Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current SOP’s, batch documentation and licenses. Liaise with Process Development and other functions regarding documentation changes in an effective and timely manner. Support a safe working environment by aligning with all pertinent environmental health/safety practice, rules and regulations. Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The manufacturing professional we seek is a collaborative partner with these qualifications. Basic Qualifications: Doctorate degree OR Master’s degree & 3 years of directly-related manufacturing experience OR Bachelor’s degree & 5 years of directly-related manufacturing experience OR Associate’s degree & 10 years of directly-related manufacturing experience OR High school diploma / GED & 12 years of directly-related manufacturing experience Preferred Qualifications: Experience participating in and leading cross-functional teams Experience with various quality systems including change control, deviations, corrective and preventative actions, and/or validation practices Project Management experience advantageous Fundamentally sound project management/organization, technical writing, digital literacy, and communication/presentation skills Independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration. Excellent teammate prepared to work in and adopt a team-based culture that relies on collaboration for effective decision-making Experience in managing multiple, competing priorities in a fast-paced environment Understanding of fill/finish operations Strong technical writing and presentation skills Ability to be flexible and manage change Ability to optimally communicate technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms Ability to communicate and collaborate with technical and management staff Direct experience with regulated environments (e.g., cGMP etc.) Thrive What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being. Vast opportunities to learn and move up and across our global organization Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits Apply now for a career that defies imagination In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us. careers.amgen.com .