Career Category Manufacturing Job Description The role The Specialist Manufacturing role will support the execution of manufacturing/quality systems such as deviation investigations, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems. This role will also be key contributor in AML6 Manufacturing-Drug Substance organization. Specific responsibilities include but are not limited to: - Applied Process Expertise - Support non-standard shift organization, including weekends and extended hours as per business needs. - Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner. - Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities. - Provide troubleshooting support. - Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process. - Process Monitoring - Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations. - Provide support of timely execution of the process monitoring quarterly reports. - Deviation and CAPA - Ensure that all Deviations are triaged within the established goal. - Responsible for authoring investigation reports. - Responsible for execution of corrective actions. - Responsible for managing NC/CAPA closure within established goal. - Monitor and communicate incidents trends. - Review equipment/system Root Cause Analysis investigations and support trend evaluations. - Process Validation - Assist with generation of process validation protocols and reports. - Assist with the execution of the process validation. - Support collection and analysis of process validation data. - Regulatory - May participate in regulatory inspections. - New Product Introductions (NPI) & Process or Equipment Modifications - Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications. - Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects. - Change Control - Assist manufacturing change owner on CCRB packages impacting the process. - Projects and Initiatives - Participate on the assessment or implementation of special projects or initiatives. The department The AML-6 Facility is the home of elite, multi-product Drug Substance Manufacturing Operations. The facility highlights the combination of groundbreaking manufacturing sciences and process technology, advanced equipment engineering and automation, and a culture of opportunities integrating cross-functional teams from across the site with the goal of achieving being the best mammalian drug substance manufacturing facility in the world. Basic qualifications - skills and education Bachelors degree & 5 years of Manufacturing experience in a GMP regulated industry OR Masters degree & 3 years of Manufacturing experience in a GMP regulated industry OR Doctorate degree Beyond that, the preferred qualifications are: - Education discipline in Life Science and/or Engineering. - Experience in Root Cause Analysis (Six Boxes, Fishbone, 5 Whys, Kepner Tregoe). - Drug substance manufacturing experience. - Strong Technical Writing Skills. - Detailed technical understanding of bio-processing unit operations. - Skilled in performance of GMP production operations. - Regulatory knowledge and interactions. - Participate and help lead cross-functional teams - Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality. - Organizational and presentation skills. - Project management skills. - Knowledge of control charting. - Availability to support non-standard shift. The benefits Our broad approach is one of the reasons why we are regularly recognized as a Best Place To Work. We offer a superior benefits package that includes an award-winning retirement and stock plan. And between the paid time off, and wellness program and on-site child care and fitness facilities you will find us focused on your well-being too. Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions. Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. 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 quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. .
