Drug Product Development Leader (Sterile Injectables)

BioSpace; Osage City (KS); On-site; USD 130,000 - 160,000; Full time

Job summary

A leading pharmaceutical company in Osage City is looking for an Associate Director of Drug Product Development. In this role, you will oversee pharmaceutical product development, manage a cross-functional project team, and ensure compliance with regulatory requirements. You must possess a doctoral degree and have a strong background in sterile injectables and regulatory knowledge. The position includes mentorship responsibilities and will require up to 20% travel.

Qualifications

• Minimum of 12 years of relevant industrial experience.
• Experience in sterile injectables and oral solid dosage forms preferred.
• Strong knowledge of regulatory expectations.

Responsibilities

• Oversee drug product development for various dosage forms.
• Lead design and execution of drug product formulation.
• Manage preparation of regulatory applications.

Skills

Problem-solving skills

Technical leadership

Regulatory knowledge

Quality by Design (QbD)

Data visualization

Education

Bachelors, Masters, or PhD in pharmaceutical sciences or related disciplines

Tools

Design of Experiments (DoE)

Statistical analysis software

Job description

A leading pharmaceutical company in Osage City is looking for an Associate Director of Drug Product Development. In this role, you will oversee pharmaceutical product development, manage a cross-functional project team, and ensure compliance with regulatory requirements. You must possess a doctoral degree and have a strong background in sterile injectables and regulatory knowledge. The position includes mentorship responsibilities and will require up to 20% travel.