Senior development engineering

Career CategoryScientificJob DescriptionJoin Amgen’s Mission of Serving PatientsAt Amgen, if you feel like you’re part of something bigger, it’s because you are. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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. Process Development Senior ScientistWhat you will doLet’s do this. The group supports drug product commercial formulation development as well as formulation/fill/finish process development for Amgen’s Late-Stage biologics portfolio.The candidate will have a strong understanding of protein attributes, stability and process-related degradation pathways, and analytical strategies for characterizing critical quality attributes (CQAs). This role will integrate formulation, analytical, and process data to guide product design and development. The successful candidate will apply innovative technologies, including AI and machine learning where appropriate, and collaborate across functions to deliver high-quality, stable, and manufacturable drug products in a fast-paced environment.Participate in Drug Product Commercialization Teams responsible for conducting process development of pipeline products and for supporting commercial products through lifecycle management Design, plan, complete, and document formulation and process development studies Apply scientific/engineering principles and techniques to develop, characterize and implement processes and next generation technologies and to solve technical challenges Apply advanced statistical/data analytics techniques to draw conclusions and inform decisions Develop and characterize liquid formulations for biologics, with particular emphasis on enzyme drug product formulation or co-formulationsBuild process understanding across unit operations to support scalable drug product developmentApply machine learning, AI, and data science to predictive modeling, workflow acceleration, and decision-making Author/review guideline documents, technical protocols and reports, risk assessments, and regulatory sections in support of IND and marketing application submissionsProvide support to clinical and commercial technology transfer activities and manufacturing operations through process fit assessments, process capability analysis, troubleshooting, root cause analysis, and product impact assessments for process changes/improvements and non-conformance investigationsStay current on the latest developments in the industry and scientific community to continue innovating and to meet future business needsEffectively and consistently communicate with management, cross-functional partners and relevant team members on progress towards achievements and forthcoming program needsLead cross functional initiatives enhancing drug product platforms and contribute to process design improvement projectsWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. Basic Qualifications:Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable]ORMaster’s degree and 3 years of ScientificexperienceORBachelor’s degree and 5 years of Scientific experiencePreferred Qualifications:PhD in Pharmaceutics, Biotechnology, Chemical Engineering, Bioengineering, Biochemistry, or related field with 2-4 years of postdoc or industry experience Experience integrating formulation, stability, and analytical data to advance biologics including enzyme, mAb and peptide candidates is highly desirable Demonstrated understanding of biologics drug product development considerations, including protein stability, degradation pathways, quality attributes, and product/process comparabilityExperience developing or characterizing enzymes, including assessment of activity, stability, and performance under relevant formulation or process conditionsExperience in formulation and co-formulation development, fill-finish process engineering, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experimentsStrong foundation in analytical and biophysical techniques relevant to biologics (e.g., UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, subvisible particle analysis, etc.)Experience with programming, application of AI-enabled tools as well as data visualization tools (e.g. Tableau, Spotfire)Skilled communicator with experience contributing to regulatory submissions (CTAs, BLAs)Strong project management skills, including the ability to manage one’s project resources (material, workforce, time, etc.)Critical thinking, problem solving and independent research skillsStrong ability to operate well in a fast-paced, matrixed environment and collaborate successfully cross-functionallyWhat you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. 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 accountsA discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plansFlexible work models where possible. comIn 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. Application deadlineAmgen 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.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. We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Salary Range126,066.05USD -170,559.95 USDSummaryLocation: US - California - Thousand OaksType: Full time