Process Development Sr Associate

Career Category Scientific 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. Process Development Sr Associate What you will do Lets do this! Lets change the world! In this vital role you will be part of our Cleaning Characterization group, based in Amgens Thousand Oaks, CA. This group is responsible for the development of cleaning process design supporting new product introduction in Amgen internal manufacturing network for both drug substance and drug product. The cleaning characterization group perform bench scale studies to enable introduction of new molecules manufacturing in Amgen Manufacturing network. The group supports investigation of deviations/non conformances, writes technical cleaning evaluation reports, and supports plant inspections, including Prior Approval Inspections (PAIs). Job Responsibilities: Design and perform planned laboratory experiments in assessment of new product cleaning with existing cleaning process. Help develop new methods, apparatus and procedures for bench-scale cleaning characterization work. Write technical reports, assessments, and procedures. Use characterization data to develop key operating parameters (KOPs), testing requirements and acceptance criteria for new product launches in manufacturing. Work with Quality, Engineering and Cleaning Validation leads to implement Cleaning process requirements at full scale. Write technical reports based on the bench scale studies supporting individual manufacturing site Cleaning validation program. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a motivated, curious and collaborative team-player with these qualifications. Basic Qualifications: High school diploma / GED and 6 years of Scientific experience OR Associates degree and 4 years of Scientific experience OR Bachelors degree and 2 years of Scientific experience OR Masters degree Preferred Qualifications: Masters or Bachelors degree in a scientific field with demonstrated ability in laboratory environment in life science industry. Design and perform bench-scale experiments, and assessment of data/results. Analytical methods: Total Organic Carbon (TOC), protein assays, gel electrophoresis, spectroscopic methods, Biological Binding Method (Bioassay, SPR or ELISA). Characterization of cleaning process processes for biologicals. Experience of writing technical reports based on laboratory studies. Good knowledge of scientific principles, methodologies and practices. Lab methods, including handling and dispensing chemicals, preparing buffers and operation of common lab equipment, such as pH and conductivity meters. Strong interpersonal skills and ability to communicate with unique background teams. Strong lab studies management(project management) skills to prioritize the lab studies based on changing priorities. Good written and verbal communication skills. 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. 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. 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. . Salary Range 85,306.00 USD - 103,484.00 USD Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen