Specialist Manufacturing-New Product Introduction (NPI)

Career Category Manufacturing Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Specialist Manufacturing, New Product Introductions What you will do Let’s do this! Let’s change the world! In this vital role you will communicate and interface between the GMP manufacturing teams in the plant and process development scientific groups. New Product Introduction lead coordinating with Supply Chain, Planning, Facilities and Engineering, Quality, as well as Manufacturing to introduce new Drug Substance products and/or advanced technologies into the plant. Technical expert who leads or participates in projects, ensuring that production documents are accurate and up to date. Support Manufacturing in troubleshooting, problem solving and RCAs. Support CAPA development to prevent error recurrence. Champions Lean Transformation and OE initiatives, facilitates the drive towards continuous improvement in the plant and tracks progress on a plant level. Collaborate with Regulatory and Quality partners to manage change control records and respond to regulatory questions and/or audit findings. Generate electronic and paper process documents to ensure plant success. Perform electronic batch record editing and troubleshooting to support production, as required. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is an individual with these qualifications. Basic Qualifications: Doctorate degree OR Master’s degree in chemistry, biology or engineering & 2 years of biotechnology operations experience OR Bachelor’s degree in chemistry, biology or engineering and 4 years of biotechnology operations experience OR Associate’s degree in chemistry, biology or engineering & 8 years of biotechnology operations experience OR High school diploma / GED & 10 years of biotechnology operations experience Preferred Qualifications: Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry Excellent technical writing skills and experience with electronic documentation systems Experience with PAS X, Werum software with capability to create and edit in EBR Experience in GMP operations Strong technical knowledge of downstream drug substance processing (chromatography, filtration, buffer compounding) and a broad understanding of upstream processing (cell culture, harvest) Ability to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc. 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 coach, mentor and/or cross train colleagues within core technical areas Background in lean manufacturing methodologies and operational excellence Experience in cross functional Project Management What you can expect from us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law. We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation. . Salary Range 107,545.40USD -145,502.60 USD