Process Development Senior Scientist - Pre-Pivotal Drug Product Technologies

Amgen•Thousand Oaks, CA

6d•$126,066 - $170,560

About The Position

The Process Development Senior Scientist will join Amgen’s Pre-Pivotal Drug Product Technologies group, which is responsible for early-stage drug product development across diverse modalities, with emphasis on monoclonal antibodies, multispecifics, and other biologics. The role focuses on developing liquid and lyophilized formulations, evaluating critical quality attributes, establishing robust and scalable fill/finish processes for complex biologic drug products, and authoring and supporting regulatory submissions. The scientist plans and executes formulation and fill/finish studies, develops and characterizes formulations, evaluates compatibility and stability under clinical conditions, and builds process understanding across unit operations. The role also develops automated, high-throughput screening and laboratory automation workflows, applying design of experiments, data analysis, machine learning, and other advanced data science approaches to guide formulation development and decision-making. The position works in a fast-paced, matrixed environment with process development, research, regulatory, manufacturing, automation, data science, and digital teams. Responsibilities include preparing technical and regulatory documentation, supporting technology transfer and manufacturing activities with internal teams and external CMOs/CDMOs, and presenting findings to stakeholders. Development approaches should be phase-appropriate from discovery through clinical manufacturing.

Requirements

Doctorate degree (PhD, PharmD, or MD); or a master’s degree and 3 years of scientific experience; or a bachelor’s degree and 5 years of scientific experience.
Strong communication skills and ability to contribute to regulatory submissions such as CTAs and BLAs.

Nice To Haves

PhD in Pharmaceutics, Biotechnology, Biochemistry, or a related field, with 2–4 years of postdoctoral or industry experience.
Experience in biologics formulation development, stability testing, and fill/finish operations; direct biologics drug product formulation experience is strongly preferred.
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.
Hands-on experience with high-throughput formulation development, automated liquid handling systems such as Hamilton, Tecan, Beckman Coulter, or Opentrons, and robotic laboratory workflows.
Experience designing and executing high-throughput biologic formulation screening studies, including automated preparation, analytical characterization, and data analysis.
Experience implementing laboratory automation, workflow digitization, and electronic data capture to improve R&D productivity.
Familiarity with design of experiments, high-throughput experimentation, laboratory robotics, and workflow orchestration for formulation and process development.
Strong foundation in biologics-relevant analytical and biophysical techniques, such as UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, and subvisible particle analysis.
Familiarity with clinical-stage development, manufacturability, and risk-based decision-making.
Experience applying AI/ML, including LLMs or in silico tools, to streamline R&D and optimize performance.

Responsibilities

Plan and execute formulation and fill/finish process studies for early-stage programs.
Develop and characterize liquid and lyophilized biologic formulations, including biologic drug product 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 critical quality attributes, including aggregation, fragmentation, charge and size variants, subvisible particles, and surface interactions.
Design, develop, and execute automated high-throughput formulation screening workflows for excipient selection, formulation optimization, and processability assessment.
Develop and implement laboratory automation solutions, including robotic liquid handling and automated sample preparation workflows.
Partner with automation engineers, data scientists, and digital teams to deploy integrated workflows for formulation development, stability studies, and process characterization.
Use design of experiments, high-throughput experimentation, and automated data analysis pipelines to explore formulation design space and support data-driven decisions.
Identify and address technology gaps affecting 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 technology-transfer packages.
Support internal and external technology transfer, including work with CMOs/CDMOs, batch record review, process fit assessments, person-in-plant support, and manufacturing campaign troubleshooting.
Present findings to internal and external stakeholders and participate in cross-functional teams.

Benefits

Health and welfare plans for staff and eligible dependents
Retirement and Savings Plan with company contributions
Medical, dental, and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program, or sales-based incentive plan for field sales representatives
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible
Career development opportunities