Process Development Senior Scientist - Pre-Pivotal Drug Product Technologies

About the role

Join Amgen’s 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.

Responsibilities

• 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.

Requirements

• Doctorate degree (PhD, PharmD, or MD) or Master’s degree and 3 years of scientific experience or Bachelor’s degree and 5 years of scientific experience.

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 (e.g., UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, subvisible particle analysis).
• Familiarity with clinical-stage development, manufacturability, and risk-based decision-making.
• Skilled communicator with experience contributing to regulatory submissions (CTAs, BLAs).

Benefits

• 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
  • 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 where possible

Pay

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.