Associate Scientist, Process Development (Process Validation & Business Strategy)

Company: Amgen
Location: Holly Springs
Posted on: January 26, 2026

Job Description:

Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Associate Scientist, Process Development (Process Validation & Business Strategy) What you will do Lets do this. Lets change the world. In this vital role you will be a part of the Process Development Drug Substance Technology group (PD DST) at Amgens FleX Batch Biologics Manufacturing Facility. This position is part of the Process Validation & Business Strategy (PBS) team within PD DST. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility, which includes process development operation support, developing digital tools to support business processes, and support commercial development of Amgens pipeline. The role will be responsible for ensuring PD business strategy operations have appropriate digital tools to track operational metrics for safety, training, compliance, support business processes improvements, and the commercial development of the Amgens pipeline. In addition, the role will be responsible for supporting tech transfer activities as needed. Lead and develop the Process Development safety, training, and compliance monitoring operation Holistic Lab Execution Environment (HLEE) champion for the process development lab Develop digital tools to improve business process efficiencies and identify bottlenecks within the process development operation Develop digital tools to support process validation and process monitoring activities Support and develop the Amgen North Carolina (ANC) PD DST knowledge management ecosystem, alignment of ANC PD business process to network practice, and optimizing the ANC PD business process. Provide process floor or lab support as required What we expect of you We are all different, yet we all use our unique contributions to serve patients. The experienced scientific professional we seek is a leader with these qualifications. Basic Qualifications: Bachelors degree and 3 years of Process Development or Scientific experience OR Masters degree and 1 years of Process Development or Scientific experience Preferred Qualifications: 2 4 years of experience in a Biotech/Pharma Process Development, MFG, QC, or laboratory role. Knowledge in broad aspects of biologics processing, for example cell culture, purification, analytical methods, or product quality attributes Familiarity in operational aspects of process development lab or commercial biopharma manufacturing Experienced with software such as Holistic Lab Execution Environment (HLEE), Tableau, MS PowerBI, spotfire, and/or databricks Able to apply digital tool skills to solve business process issues and evaluate opportunities for process improvements Excellent written and verbal communication Be a self-starter with the ability to take on several projects at one time. What you can expect of 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, well support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com 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 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 and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Keywords: Amgen, Winston-Salem , Associate Scientist, Process Development (Process Validation & Business Strategy), Science, Research & Development , Holly Springs, North Carolina