Process Development Senior Scientist - Pre-Pivotal Drug Product Technologies

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 Sr Scientist What you will doLet’s do this. Let’s change the world. In this vital role you will join Pre-Pivotal Drug Product Technologies group, responsible for early-stage drug product development across diverse modalities, with a strong emphasis on monoclonal antibodies, multispecifics and other biologic modalities. The role involves designing and developing liquid and lyophilized formulations; evaluating critical quality attributes (CQAs); establishing robust, scalable fill/finish processes for complex biologic drug products; and authoring and supporting high quality regulatory submissions. Work effectively in a fast-paced, matrixed environment, collaborating across process development, research, regulatory, and manufacturing teams to advance programs and communicate technical recommendations to both scientific peers and leadership.Plan and execute formulation and fill/finish process studies for early-stage programs.Develop and characterize liquid and lyophilized formulations for biologics, with particular emphasis on biologics drug product formulation, handling, and lab-scale sterile filling.Build process understanding across unit operations to support scalable drug product development.Evaluate in-use compatibility and drug product stability under clinical conditions.Investigate biologics-relevant CQAs (e.g., aggregation, fragmentation, charge/size variants, subvisible particles, surface interactions) to inform formulation and process design decisions.Identify and address technology gaps impacting biologics stability, protein-excipient interactions, and process-related stress responses.Apply machine learning, AI, laboratory automation, and advanced data science to predictive modeling, workflow acceleration, and decision-making.Ensure development approaches are phase-appropriate, from discovery through clinical manufacturing.Author technical documents, control-strategy inputs, risk assessments, IND/CTA regulatory sections, and tech transfer packages.Support internal and external technology transfer activities, including collaboration with CMOs/CDMOs, batch record review, process fit assessments, person-in-plant support, and troubleshooting during manufacturing campaigns.Present findings to internal/external stakeholders and participate in cross-functional teams.What 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 MDORMaster’s degree and 3 years of Scientific experienceORBachelor’s degree and 5 years of Scientific experiencePreferred Qualifications:PhD in Pharmaceutics, Biotechnology, Biochemistry, or related field with 2–4 years of postdoc or industry experience. Proven experience in formulation development, stability testing, and fill/finish operations for biologics; direct biologics drug product formulation experience is strongly preferred.Demonstrated understanding of biologics drug product development considerations, including protein degradation, quality attributes, and product/process comparability.Experience integrating formulation, stability, and analytical data to advance biologics candidates from discovery or preclinical development into clinical manufacturing is highly desirable.• Experience implementing laboratory automation, workflow digitization, AI/ML (e.g., LLMs, in silico tools) or electronic data capture to improve R&D productivity.Strong foundation in analytical and biophysical techniques relevant to biologics and biologics (e.g., UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, subvisible particle analysis, etc.).Familiarity with clinical-stage development, manufacturability, and risk-based decision-making.Skilled communicator with experience contributing to regulatory submissions (CTAs, BLAs).What you can expect from 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. 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..Salary Range126,066.05USD -170,559.95 USDSummaryLocation: US - California - Thousand OaksType: Full time