Process Development Senior Scientist - Drug Product Technologies

Amgen•Thousand Oaks, CA

3d•$126,066 - $170,560

About The Position

The Process Development Senior Scientist will join Amgen’s Pre-Pivotal Drug Product Technologies group, which develops early-stage drug products across diverse modalities, with particular emphasis on antibody-drug conjugates (ADCs), as well as monoclonal antibodies, multispecifics, and other biologics. The role focuses on designing and developing liquid and lyophilized formulations, evaluating critical quality attributes, establishing robust and scalable fill/finish processes, and authoring and supporting regulatory submissions. The successful candidate will bring hands-on ADC drug product formulation and process development experience, including understanding of linker-payload attributes, stability and process-relevant degradation pathways, and analytical strategies for characterizing ADC quality attributes. The scientist integrates formulation, analytical, and process data to guide product design; applies emerging technologies, including AI/ML; and collaborates across teams to deliver stable, high-quality, manufacturable drug products for clinical development. The work takes place in a fast-paced, matrixed environment and covers phase-appropriate development from discovery through clinical manufacturing.

Requirements

Doctorate degree (PhD, PharmD, or MD), with relevant postdoctoral experience where applicable; or a master’s degree and 2 years of scientific experience; or a bachelor’s degree and 4 years of scientific experience.
Experience in formulation development, stability testing, and fill/finish operations for biologics.
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.
Strong foundation in analytical and biophysical techniques relevant to ADCs and biologics, such as UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, and subvisible particle analysis.
Ability to integrate formulation, stability, and analytical data to support development of drug product candidates.
Familiarity with clinical-stage development, manufacturability, and risk-based decision-making.
Strong communication skills and experience contributing to regulatory submissions such as CTAs or BLAs.

Nice To Haves

PhD in Pharmaceutics, Biotechnology, Biochemistry, or a related field, with 2–4 years of postdoctoral or industry experience.
Direct ADC drug product formulation experience.
Experience advancing ADC candidates from discovery or preclinical development into clinical manufacturing by integrating formulation, stability, and analytical data.
Experience applying AI/ML, such as LLMs or in silico tools, to streamline R&D and optimize performance.

Responsibilities

Collaborate with process development, research, regulatory, and manufacturing teams, and communicate technical recommendations to scientific peers and leadership.
Plan and execute formulation and fill/finish process studies for early-stage programs.
Develop and characterize liquid and lyophilized biologic formulations, particularly ADC formulations, 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 ADC- and biologics-relevant critical quality attributes, including aggregation, fragmentation, drug-to-antibody ratio, free payload, charge and size variants, subvisible particles, and surface interactions.
Use high-throughput tools for formulation screening and processability assessments.
Identify and address technology gaps affecting ADC stability, linker-payload integrity, protein-excipient interactions, and process-related stress responses.
Apply machine learning, AI, and data science to predictive modeling, workflow acceleration, and decision-making.
Ensure development approaches are appropriate to the phase, 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 CMO/CDMO collaboration, 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.