Analytical Sr 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. Analytical Sr Scientist What You Will Do Lets do this! Lets change the world! Responsibilities Integrate and successfully apply platform and prior product knowledge to advance Amgen practices and ensure success from FIH study through to marketing application. Define analytical control strategies and implement methodologies for development of pivotal phase clinical programs. Collaborate closely with drug substance and drug product process development colleagues. Manage activities at contract manufacturing and testing sites. May lead and develop a small group of scientists. 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 collaborative partner with these qualifications. Basic Qualifications Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] OR Masters degree and 3 years of Scientific experience OR Bachelors degree and 5 years of Scientific experience Preferred Qualifications PhD in Analytical Chemistry, Organic Chemistry, Materials Science, Biochemistry, Biochemical or Chemical Engineering Experience in the pharmaceutical or biotech industry in process and product development and drug substance and drug product analytical method development is a plus. Strong understanding of small molecule analysis, structure elucidation and solid-state characterization guided and informed by knowledge of organic chemistry. Experience in a wide variety of analytical techniques including chromatography(HPLC and UPLC) mass spectrometry, UV, NMR, FTIR, solid state characterization, etc. Developing and implementing methods for in-process testing, release and stability testing. Experience in analytical testing requirements for immediate release and controlled release oral solid dosage drug products. Familiarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation, impurities, mutagenic impurities, etc. Solid understanding of GLP and GMP requirements and their application in a phase appropriate manner Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations, able to manage deliverables against timelines Strong communication skills and ability to provide cross-functional leadership and guidance to CMC and non-clinical teams, e.g. informing and defending the Quality Target Product Profile Works well in cross-functional teams, and across various geographic locations in different time zones Excellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing documents 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 where possible. Refer to the Work Location Type in the job posting to see if this applies. 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. Application deadline Amgen 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. Sponsorship Sponsorship 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. #J-18808-Ljbffr BioSpace