Process Development Senior Scientist Pre-Pivotal Drug Product

Company: Amgen
Location: Thousand Oaks
Posted on: June 27, 2025

Job Description:

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. 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. Process Development Senior Scientist Pre-Pivotal Drug Product What you will do Lets do this! Lets change the world! In this vital role Amgen is seeking a Process Development Senior Scientist for the Pre-Pivotal Drug Product Technologies group in Thousand Oaks, CA. This role supports early-stage drug product development across diverse modalities including monoclonal antibodies, bispecifics, fusion proteins, antibody-drug conjugates, and oligonucleotides. The role involves designing and developing liquid, frozen, and lyophilized formulations; evaluating critical quality attributes (CQAs) relating to shelf-life stability, and in-use stability; and establishing robust, scalable fill/finish and drug product processes. The ideal 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 clinical development. Responsibilities will include: Plan and execute formulation and fill/finish process studies for early-stage programs. Develop and characterize formulations (liquid, lyophilized, frozen) and lab-scale sterile filling. Build process understanding across unit operations to support scalable drug product strategies. Evaluate in-use compatibility and drug product stability under clinical conditions. Investigate CQAs (e.g., aggregation, chemical modification, surface interactions, etc.) to inform formulation and process decisions. Leverage high-throughput tools for formulation screening and processability assessments. Identify and address gaps in technologies impacting protein stability and interactions. Apply machine learning, AI, and data science to predictive modeling, workflow acceleration, and decision-making. Ensure development approaches are phase-appropriate, from discovery through clinical manufacturing. Author technical documents, risk assessments, IND/CTA/BLA regulatory sections, and tech transfer packages. Support successful technology transfer to manufacturing (internal or external CMOs). Present findings to internal/external stakeholders and participate in cross-functional teams. 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 Self-starter with these qualifications. Basic Qualifications: Bachelors degree and 5 years of scientific experience OR Masters degree and 3 years of scientific experience OR Doctorate degree PhD OR PharmD OR MD and relevant post-doc where applicable Preferred Qualifications: PhD in Pharmaceutics, Biotechnology, Biochemistry, Physical Biochemistry, or related field with 24 years of postdoctoral or industry experience. Proven experience in formulation development, stability testing, and fill/finish operations for biologics. Strong foundation in analytical and biophysical techniques (e.g., UPLC/HPLC, SEC, IEX, RP-HPLC, CE-SDS) applied to drug product development. Familiarity with phase appropriate development, manufacturability, and risk-based decision-making. Experience applying AI/ML (e.g., LLMs, in silico tools) to streamline innovation, processes, and optimize performance. Skilled communicator with experience presenting technical and strategic content across functional teams. Demonstrated experience with contributing to regulatory submissions including authoring CTAs, amendments, and/or BLAs. 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, 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, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team. 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.

Keywords: Amgen, Paramount , Process Development Senior Scientist Pre-Pivotal Drug Product, Science, Research & Development , Thousand Oaks, California