Associate Scientist

Career CategoryOperationsJob DescriptionJoin Amgen’s Mission of Serving PatientsAt 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.Process Development Associate ScientistWhat you will doLet’s do this. Let’s change the world. In this vital role you will contribute to our diverse early-stage portfolio projects that support different therapeutic modalities (bispecific/multispecific, fusion proteins, mAbs, ADCs and oligonucleotides). The candidate is expected to have hands-on experience in formulation development and stability characterization of large molecule drug candidates to assess their critical quality attributes supporting diverse therapeutic areas. The candidate will be responsible for drug product formulation and process development by providing scientific and technical expertise to advance the pre-pivotal portfolio.Routinely plan, design, complete, and document stability studies related to FIH formulation development and fill/finish process development, in support of product commercialization.Responsible for design and execution of in use compatibility studies for clinical to mimic clinical dose preparation and administrationConduct stability studies, to support liquid and lyophilized formulations. This will require knowledge of ultrafiltration-diafiltration and other buffer exchange processes.Complete development of multi-modality protein drug formulations and analytical characterization of proteins via HPLC/UPLC/2-D HPLC methods, subvisible particle analysis, viscosity characterization, mass spectrometry, capillary electrophoresis, biophysical analysis.Active participation and representation of drug product process development group in cross-functional project teams across organizationContinuous adherence to compliance and quality and compliance while meeting organization’s goals and prioritiesAuthor/review guideline documents, technical protocols, technical transfer documentation, reports, product impact assessments, and regulatory sections in support of IND submissionsStay current on the latest developments in the industry and scientific community to continue innovating and to meet future business needsMeticulous data collection, documentation using electronic data capture systemsAbility to work in a matrixed team and present data cross functionallyWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.Basic Qualifications:Master’s degreeORBachelor’s degree and 2 years of Scientific experienceORAssociate’s degree and 4 years of Scientific experienceOR High school diploma / GED and 6 years of Scientific experiencePreferred Qualifications:Master’s degree in Pharmaceutics, Biotechnology, Biochemistry, Physical Biochemistry, Biophysics, or related field with a minimum of 3+ years of industrial experience in pharmaceutical/biotechnology or related fieldUnderstanding of physical/chemical stability of proteins and how process related stress impacts product qualityExperience in antibody characterization, stability, and experience in development of parenteral control release delivery systemsSophisticated understanding of predictive methods, protein stability and solubilityPreferred experience in biophysical analysis (Light scattering, DSF, AUC, FFF), mass spectrometry (peptide mapping), high throughput screening and data analyticsPreferred understanding of drug delivery and devices related to product developmentProficiency in statistical software (such as JMP), experience with data visualization tools or packages (Tableau or Spotfire)Strong independent problem-solving skillsAbility to learn and act on dynamic information at a rapid pace, hard-working and collaborative attitudeExcellent oral and written communication skills for timely documentation, presentation, and discussion of scientific results for a fast pace and cross functional environment.What 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. From our competitive benefits to our collaborative culture, we’ll 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 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. Refer to the Work Location Type in the job posting to see if this applies.Apply now and make a lasting impact with the Amgen team.careers.amgen.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. You will not be penalized for redacting or removing this information.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.SponsorshipSponsorship for this role is not guaranteed.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 Range90,442.55USD -122,363.45 USDSummaryLocation: US - California - Thousand OaksType: Full time