Process Development Senior Principal 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 Senior Principal Scientist What you will doLet’s do this. Let’s change the world. In this vital role you will join our Pivotal Drug Product Technologies group in Thousand Oaks, CA. This group supports drug product commercial formulation development as well as formulation/fill/finish process development for Amgen’s Late-Stage biologics.The Senior Principal Scientist will provide technical and project leadership while integrating information generated by functionally diverse teams to ensure success through the commercialization process.The ideal candidate will bring hands-on experience in ADC drug product formulation and drug product process development, including a mechanistic understanding of linker-payload attributes, stability/process-relevant degradation pathways, and analytical strategies used to characterize ADC CQAs. This candidate will integrate formulation, analytical, and process data to guide product design, apply cutting-edge technologies (including AI/ML), and collaborate cross-functionally to deliver high-quality, stable, and manufacturable drug products for development in a fast-paced environment. Lead planning, design, execution, and documentation of laboratory studies related to drug product design, formulation, and process development, and tech transferDeliver progress reports and presentations to ensure management awareness and engagement of the status, progress, and future program and functional needsAuthor and review guideline documents, technical protocols, reports, product impact assessments, regulatory submissions, and developing responses to regulatory questionsDevelop and characterize liquid and lyophilized formulations for biologics, with particular emphasis on ADC drug product formulation, handling, and lab-scale sterile filling. Lead internal and external technology transfer activities, including collaboration with CMOs/CDMOs, process fit assessments, and troubleshooting during manufacturing campaigns. Apply machine learning, AI, and data science to predictive modeling, workflow acceleration, and decision-making. Serve as a Drug Product Team Lead of a matrixed team to develop strategy in support of commercialization and life cycle management of Amgen’s pipelineManage team of engineers and scientists to advance program and functional objectivesWork effectively in a highly matrixed team environment to influence and inspire change, efficiency, and foster positive relationshipsAbility to travel domestically and internationally up to 10% of the timeWhat 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:Doctorate degree PhD OR PharmD OR MD and 2 years of Scientific experienceORMaster’s degree and 5 years of Scientific experienceORBachelor’s degree and 7 years of Scientific experiencePreferred Qualifications:Advanced degree in Engineering, Pharmaceutics, Biotechnology, Material Science or related subject area8+ years of experience in pharmaceuticals/biotechnology5+ years of experience that includes elements of formulation and fill/finish process development, process characterization, technical transfers to manufacturing sites, and statistical design and analysis of experiments, and regulatory authoringProven experience in formulation development, stability testing, and fill/finish operations for biologics; direct ADC drug product formulation experience is strongly preferred. Demonstrated understanding of ADC drug product development considerations, including linker-payload stability, drug-to-antibody ratio, free drug or payload degradation, quality attributes, and product/process comparability. Experience integrating formulation, stability, and analytical data to advance ADC candidates is highly desirable. Strong foundation in analytical and biophysical techniques relevant to ADCs and biologics (e.g., UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, subvisible particle analysis, etc.). Technical leader with demonstrated results driving forward programsExperience in drug product regulatory strategy, RTQs, and agency engagementKnowledge of, and hands-on experience with, bringing new biotech products to market, across various dosage forms and device delivery systemsExperience with programming (e.g. Python, R, MATLAB) and database languages (e.g.SQL), as well as data visualization tools (e.g. Tableau, Spotfire, D3js)Proficiency in at least one statistical software package (e.g. SAS, JMP or Minitab)Experience participating and leading global multi-functional teamsOutstanding knowledge of formulation, aseptic processing and manufacturing of biotechnology products, vials, syringes, cartridges, devices, disposables, modeling, and the associated GMP/Device documentation and regulatory filingsStrong problem solving and effective multi-functional interpersonal skillsWilling and able to learn new technologies at a rapid paceWhat 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 Range157,737.05USD -213,408.95 USDSummaryLocation: US - California - Thousand OaksType: Full time