Associate Director, Lipid Formulation & Tech Transfer

Planet Pharma; California (MO); On-site; USD 120,000 - 160,000; Full time

Job summary

A leading pharmaceutical company is seeking an Associate Director of Product Development in California. This role will focus on the development of lipid and peptide formulations, requiring expertise in lyophilization and regulatory compliance. The ideal candidate has a Ph.D. and extensive experience in drug delivery technologies. Responsibilities include overseeing product development, establishing a laboratory, and ensuring effective collaboration with CDMOs.

Qualifications

• 8–10 years in lipid formulations or drug delivery technologies.
• Experience authoring CMC dossiers for FDA, EMA.
• Knowledge of Good Manufacturing Practices and relevant regulations.

Responsibilities

• Oversee product development for biologics, proteins, and peptides.
• Establish and manage a development laboratory.
• Lead product characterization and scale-up.

Skills

Lipid formulations

Lyophilization processes

Hands-on formulation development

Regulatory submissions knowledge

Cross-functional collaboration

Analytical problem-solving

Education

Ph.D. in Pharmaceutical sciences, Chemical engineering, Biochemical engineering

Job description

A leading pharmaceutical company is seeking an Associate Director of Product Development in California. This role will focus on the development of lipid and peptide formulations, requiring expertise in lyophilization and regulatory compliance. The ideal candidate has a Ph.D. and extensive experience in drug delivery technologies. Responsibilities include overseeing product development, establishing a laboratory, and ensuring effective collaboration with CDMOs.