Associate Scientist

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. 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, 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 Associate Scientist What you will do 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 administration Conduct 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 organization Continuous adherence to compliance and quality and compliance while meeting organizations goals and priorities Author/review guideline documents, technical protocols, technical transfer documentation, reports, product impact assessments, and regulatory sections in support of IND submissions Stay current on the latest developments in the industry and scientific community to continue innovating and to meet future business needs Meticulous data collection, documentation using electronic data capture systems Ability to work in a matrixed team and present data cross functionally What We Expect Of You Basic Qualifications Masters degree OR Bachelors degree and 2 years of Scientific experience OR Associates degree and 4 years of Scientific experience OR High school diploma / GED and 6 years of Scientific experience Preferred Qualifications Masters 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 field Understanding of physical/chemical stability of proteins and how process related stress impacts product quality Experience in antibody characterization, stability, and experience in development of parenteral control release delivery systems Sophisticated understanding of predictive methods, protein stability and solubility Preferred experience in biophysical analysis (Light scattering, DSF, AUC, FFF), mass spectrometry (peptide mapping), high throughput screening and data analytics Preferred understanding of drug delivery and devices related to product development Proficiency in statistical software (such as JMP), experience with data visualization tools or packages (Tableau or Spotfire) Strong independent problem-solving skills Ability to learn and act on dynamic information at a rapid pace, hard-working and collaborative attitude Excellent 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 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. 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. Sponsorship for this role is not guaranteed. 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. 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 BioSpace