Process Development Senior Scientist

Process Development Senior Scientist

In this vital role you will have the opportunity to work on complex synthetic molecule platforms, including targeted protein degraders, PROteolysis TArgeting Chimeras (PROTACs), molecular glues, and other beyond-rule-of-5 compounds with challenging physicochemical and biopharmaceutical properties.

The scientist will primarily design and execute formulation and process development studies for oral solid dosage forms, ranging from conventional oral solid dosage formulations to advanced enabling formulation strategies intended to overcome solubility, dissolution, absorption, and bioavailability limitations. The scientist will develop robust, scalable, and phase‑appropriate formulations suitable for IND‑enabling studies and GMP clinical manufacturing. This role provides significant opportunity to influence drug product strategy and advance next‑generation oral delivery capabilities across Amgen’s synthetic molecule portfolio.

The individual will work closely with internal manufacturing and external manufacturing partners to support process scale‑up, GMP clinical manufacturing, technology transfer, and regulatory submissions. The scientist may support multiple fast‑paced programs across oncology and other therapeutic areas with varying molecular and formulation complexities.

• Serve as the Drug Product Team Lead and primary Drug Product functional representative on cross‑functional synthetic molecule development teams.
• Independently lead drug product development strategy and execution for early clinical synthetic molecule programs.
• Lead and execute drug product development activities with a focus on right‑first‑time delivery, proactive risk management, and on‑time achievement of program milestones.
• Design and execute formulation and process development experiments for oral solid dosage forms, including platform and enabling formulations.
• Apply scientific understanding of material properties, biopharmaceutics, and manufacturability to formulation strategy selection and process development.
• Identify technical risks, develop mitigation strategies, and drive solutions to support program timelines and clinical objectives.
• Partner effectively across internal functions and external CMOs to support program execution, technology transfer, scale‑up, and GMP clinical manufacturing.
• Author and review technical and regulatory documentation including INDs, CTAs and related CMC submissions.
• Present technical strategies, development plans, risks, and recommendations to cross‑functional teams and governance forums.
• Contribute to continuous improvement initiatives and advancement of formulation and process development capabilities.

• Doctorate degree PhD or PharmD or MD (and relevant post‑doc where applicable).
• OR Master’s degree and 3 years of Scientific experience.
• OR Bachelor’s degree and 5 years of Scientific experience.

• Ph.D. in Pharmaceutical Sciences, Bioengineering, Chemical Engineering, Chemistry, or related scientific discipline with emphasis on oral drug product development for advanced synthetic modalities including degraders and PROTACs.
• Industry experience supporting early clinical drug product development programs.
• Hands‑on experience with enabling solubility formulation technologies including hot melt extrusion (HME), spray dried dispersions (SDD), and downstream processing for oral solid dosage forms.
• Experience supporting oral solid dosage form process development, scale‑up, technology transfer, and GMP clinical manufacturing.
• Strong understanding of formulation development for poorly soluble compounds and enabling bioavailability enhancement strategies.
• Experience serving as a Drug Product or Formulation Development representative on interdisciplinary and multidisciplinary teams.
• Experience authoring regulatory documentation including INDs, CTAs, and related RTQs.
• Excellent interpersonal and verbal/written communication skills with demonstrated ability to manage complex cross‑functional project activities.

• A comprehensive employee benefits package, including a Retirement and Savings Plan with…