Rockville, MD, 20851, USA
12 hours ago
Analytical Chemist - Process Development Senior Scientist
**Join Amgen’s Mission of Serving Patients** At 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. 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. **Analytical Chemist - Process Development Senior Scientist** **What you will do** Let’s do this! Let’s change the world! Amgen is currently seeking a Sr. Scientist - Analytical Chemist in our Pre-Pivotal Development team in Rockville, MD. This group is responsible for early phase analytical development, including method development, method qualification, method transfer, process and product development support. The individual will work closely with a team of analysts and scientists responsible for the technical aspects of developing the analytical tools to gain understanding of key attributes in product and process for early phase protein therapeutic programs. The Sr. Scientist will integrate and successfully use platform and prior product knowledge to advance Amgen practices and ensure success from clinical candidate selection to IND filings. + Work in a cross-functional team environment to advance therapies in early-stage development. + Analyze early-stage protein-based therapies with advanced techniques such as liquid chromatography, mass spectrometry, capillary electrophoresis, as well as other methods. + Troubleshoot and maintain laboratory equipment. + Analytical method development, qualification, transfer to GMP group. + Support process development including upstream (cell line, cell bank, cell culture development), downstream (impurities analysis, in process testing), formulation group (formulation screening, compatibility) and protein characterizations. Support research group’s molecules generations, validation, and potential new molecule nomination for clinical study. + Define analytical control strategies and implement methodologies for development of early phase clinical programs. + Mange project work packages or workflows independently. + Integrates results both within work group and cross-functional groups into experimental design. + Other duties include data analysis, preparation of electronic notebook records of experimental data, authorship of technical protocols and reports, presentation of results at team meeting, and support for regulatory filings as needed. **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 an individual with these qualifications. **Basic Qualifications:** + Bachelor’s degree and 5 years of Scientific experience OR + Master’s degree and 3 years of Scientific experience OR + Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] **Preferred Qualifications:** + Excellent laboratory skills with 3+ years of experience in industry laboratories supporting analysis and characterization of protein therapies. + Advanced technical expertise in analytical methodologies used to characterize protein therapeutics including LC-MS, HIC, SEC, IEX, RP, HILIC, CE-SDS, cIEF etc. + Expertise handling, troubleshooting, and maintaining CE and LC/MS instruments + Expertise using CE and LC/MS operation and data analysis software. + Ability to develop and implement methods for in-process, release, and stability testing. + Strong understanding of protein analysis, structure elucidation and characterization. + Solid understanding of GLP and GMP requirements and their application in a phase appropriate manner. + 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 from 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, 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 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** **for a career that defies imagination** Objects in your future are closer than they appear. Join us. **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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. 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.
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