Senior Scientist, Drug Product & Formulation Development

BioSpace; Thousand Oaks (CA); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental and vision coverage

Stock-based incentives

Flexible work models

Job summary

Amgen is seeking a Process Development Senior Scientist to lead drug product development and execution for early clinical synthetic molecule programs. You will design robust formulations and work with internal and external partners to enable scale-up and GMP manufacturing.

The role offers opportunities to influence drug product strategy, contribute to INDs/CTAs, and mentor teams while advancing next-generation oral delivery capabilities across oncology and other therapeutic areas.

Qualifications

• Doctorate degree (PhD OR PharmD OR MD) with post-doctoral experience if applicable.
• Masters with 3+ years of scientific experience; or a Bachelors with 5+ years of scientific experience.
• Experience with enabling solubility formulation technologies (HME, SDD) and GMP clinical manufacturing.

Responsibilities

• Lead drug product development strategy for early clinical programs.
• Design and execute formulation and process development experiments for oral solid dosage forms.
• Collaborate with internal functions and CMOs for technology transfer and scale-up.
• Prepare and review INDs, CTAs, and related regulatory documentation.
• Present development plans, risks, and recommendations to cross-functional teams.

Skills

Interpersonal communication

Verbal/written communication

Problem solving

Cross-functional collaboration

Risk management

Education

PhD or PharmD or MD

Masters with 3 years scientific experience

Bachelors with 5 years scientific experience

Tools

Hot Melt Extrusion (HME)

Spray Dried Dispersions (SDD)

GMP Clinical Manufacturing

Job description

Amgen is seeking a Process Development Senior Scientist to lead drug product development and execution for early clinical synthetic molecule programs. You will design robust formulations and work with internal and external partners to enable scale-up and GMP manufacturing.

The role offers opportunities to influence drug product strategy, contribute to INDs/CTAs, and mentor teams while advancing next-generation oral delivery capabilities across oncology and other therapeutic areas.