Associate Scientist, Process Development

Company: Amgen
Location: Cambridge
Posted on: October 9, 2020

Job Description:

The Associate Scientist, Process Development will provide technical input and support to Amgen's drug product commercialization team and advancement of synthetic process development. This role is important for Amgen's success and will be a key contributor to drug product and process development, commercialization and life cycle management of Amgen's product portfolio. As such the Associate Scientist will operate in product and process development and/or manufacturing environments and will be responsible for the design and execution of characterization studies, evaluation of product impact from manufacturing process, production scale, equipment, and raw material changes, authoring high-quality process transfer and other technical documents, and participating in authoring relevant sections of regulatory submissions to enable successful introduction of new processes and/or production facilities. The Associate Scientist will apply fundamental scientific (biochemistry, biophysics, statistics, etc.) and engineering principles to support nonconformance investigations and development of corrective/preventive actions. As a key contributor to Amgen's commercialization development and process introduction into clinical and commercial facilities, the Associate Scientist will integrate and utilize knowledge and information generated by cross functional (engineering, analytical, quality, regulatory, clinical and commercial manufacturing) teams to utilize Amgen platforms and capabilities to ensure success through the commercialization lifecycle. Specific Responsibilities Include - Work within a team of process scientists and/or engineers to design, execute, document, and generate primary data packages related to process development and technology transfer, while applying their experience in oral solid dosage and synthetic characterization. - Support technology transfers of pipeline and commercial products as well as lifecycle management of commercial products. - Participate in global cross-functional teams, working effectively in a highly matrixed team environment to advance programs. - Basic Qualifications Master's degree & 2 years of scientific experience OR Bachelor's degree & 4 years of scientific experience Preferred Qualifications - 6+ years of drug product process development experience in the pharmaceuticals/biotechnology Industry - Knowledge of/hands-on experience with end-to-end development of oral solid dosage drug products in various presentations - Experience with unit operations for oral solid dosage manufacturing (i.e. milling, granulation, blending, etc.), specific scale-down model development, characterization, and scale-up - Familiarity with manufacturing, cGMPs, statistical design, analysis of experiments, and process characterization - Process scale-up and technology transfer experience including the use of gap analysis, root cause analysis, and risk assessment tools - The ability to use engineering principles to leverage bench and pilot scale models for process performance characterization - Problem solving and communication skills - Experience with conducting statistical evaluations of data to evaluate statistical significance, assess potential correlations, evaluate process capability and/or perform Monte Carlo simulations. - Ability to learn and act on dynamic information at a rapid pace Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. 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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. 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, or disability status.

Keywords: Amgen, Cambridge , Associate Scientist, Process Development, Other , Cambridge, Massachusetts