Scientist/ Senior Engineer - Drug Product Process Engineering

Scientist/ Senior Engineer – Drug Product Process Engineering In this role you will serve as Process Engineering Lead providing technical and project leadership for drug product formulation, fill/finish, inspection, and presentation‑specific activities. The position supports clinical and commercial manufacturing operations, technology transfers, new product introductions, process characterization, optimization, and product impact assessments. It requires close collaboration with cross‑functional partners across Process Development, Manufacturing, Quality, Regulatory, Attribute Sciences, Engineering, Supply Chain, and Commercial Operations. Responsibilities Serve as the Drug Product SKU Lead for assigned commercial or late‑stage pipeline products, providing end‑to‑end technical ownership for formulation, fill/finish, presentation, and lifecycle management activities. Lead or support commercial technology transfers, including facility‑fit assessments, make‑a‑batch assessments, process gap analyses, risk assessments, process characterization studies, technical documentation, and on‑site manufacturing support. Act as a Process Engineering Lead for parenteral drug product unit operations, including formulation, mixing, sterile filtration, filling, capping, lyophilization, visual inspection, and related equipment/process interfaces. Plan, design, execute, and document laboratory, offline, and on‑site studies related to drug product process development, process characterization, scale‑up, process robustness, and lifecycle management. Provide technical leadership for assigned SKUs by integrating process understanding, product quality attributes, manufacturing performance, analytical data, regulatory commitments, and site capabilities. Support clinical and commercial manufacturing operations through process capability analysis, troubleshooting, root cause analysis, non‑conformance investigations, corrective and preventive actions, and product impact assessments. Author and review technical protocols, study reports, process transfer documents, product impact assessments, regulatory submission sections, responses to regulatory questions, and lifecycle management documentation. Partner with manufacturing sites and cross‑functional teams to assess and implement process changes, equipment changes, raw material changes, scale changes, site transfers, and process improvements while ensuring product quality and supply continuity. Apply scientific and engineering principles, including biochemistry, biophysics, statistics, chemical engineering, mechanical engineering, automation, and equipment design, to solve complex technical challenges. Use data‑driven approaches, statistical analysis, process monitoring, modeling, and advanced digital or AI‑enabled tools to improve process understanding, manufacturing robustness, and technology transfer efficiency. Lead or participate in global cross‑functional teams in a highly matrixed environment, influencing decision‑making, communicating risks, and driving alignment across stakeholders. Deliver clear technical updates, progress reports, risk assessments, and recommendations to management, program teams, governance forums, and manufacturing partners. Build and sustain strong partnerships with Drug Product Technologies, Attribute Sciences, Manufacturing, Quality, Regulatory, Engineering, Supply Chain, and site teams to ensure alignment between product needs, process requirements, and site capabilities. Basic Qualifications Doctorate degree Or Master’s degree and 2 years of Operations, Process Development, Scientific, or Engineering experience Or Bachelor’s degree and 4 years of Operations, Process Development, Scientific, or Engineering experience Preferred Qualifications M.S. or Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences, Pharmaceutics, Chemistry, Biochemistry, Biotechnology, Material Science, or a related technical discipline. 3+ years of experience in drug product process development, process engineering, commercialization, manufacturing sciences, or lifecycle management within the pharmaceutical or biotechnology industry. Experience supporting parenteral drug product development and manufacturing, including liquid and/or lyophilized presentations. Hands‑on or technical experience with fill/finish unit operations such as formulation, mixing, sterile filtration, filling, capping, lyophilization, visual inspection, and process scale‑up. Experience serving as a technical lead, SKU lead, process lead, or commercialization lead for late‑stage or commercial drug product programs. Experience with process characterization, scale‑down model development, scale‑up, technology transfer, process validation support, and commercial manufacturing support. Familiarity with aseptic processing, cGMPs, ICH guidelines, regulatory filings, pre‑approval inspections, and GMP documentation. Experience with non‑conformance investigations, root cause analysis, product impact assessments, process capability analysis, statistical process control, design of experiments, and risk assessment tools. Strong understanding of how process parameters, equipment, raw materials, scale, site differences, and process‑related stresses can impact product quality. Ability to analyze large and complex data sets using statistical tools, process monitoring approaches, modeling, or digital systems. Familiarity with AI‑enabled tools or advanced analytics for process characterization, process monitoring, knowledge management, and data‑driven decision‑making. Demonstrated ability to work effectively in a matrixed, global team environment and influence across functions without direct authority. Strong communication, technical writing, facilitation, organization, and stakeholder‑management skills. Ability to manage dynamic information, prioritize across multiple programs or SKUs, and drive decisions in a fast‑paced environment. Ability to travel domestically and internationally, as business needs require. What You Can Expect Of Us We offer a comprehensive 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. In addition to the base salary, the total rewards plan may include a discretionary annual bonus program, stock‑based long‑term incentives, award‑winning time‑off plans, and flexible work models where applicable. Salary 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. Equal Opportunity 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 provide reasonable accommodation to individuals with disabilities to participate in the job application or interview process and perform essential job functions. #J-18808-Ljbffr Amgen