Scientist/ Senior Engineer Drug Product Process Engineering

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity‑related conditions. 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. Scientist/ Senior Engineer Drug Product Process Engineering What you will do Let’s do this. Let’s change the world. In this vital role you will serve as Process Engineering Lead providing technical and project leadership for drug product formulation, fill/finish, inspection, and presentation‑specific activities. This role will integrate process, product, manufacturing, quality, regulatory, and analytical information to ensure successful commercialization, robust lifecycle management, and reliable supply of assigned drug product SKUs. The role will support clinical and commercial manufacturing operations, technology transfers, new product introductions, process characterization, process optimization, and product impact assessments. The candidate will work closely with global cross‑functional partners, including Process Development, Manufacturing, Quality, Regulatory, Attribute Sciences, Engineering, Supply Chain, and Commercial Operations. This position may support Amgen’s global drug product manufacturing network, including commercial sites, contract manufacturing partners, and internal development/manufacturing facilities. Domestic and international travel may be required. 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. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The scientific professional we seek is an individual with these qualifications. Basic Qualifications Doctorate degree OR Masters degree and 2 years of Operations, Process Development, Scientific, or Engineering experience OR Bachelors 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 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 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 where possible. Refer to the Work Location Type in the job posting to see if this applies. 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. #J-18808-Ljbffr Initial Therapeutics, Inc.