Description

You will act as the technical interface between formulation scientists and manufacturing operations to develop sterile drug product processes and container closure systems.

Responsibilities

• Design, develop, scale-up, and validate sterile drug product unit operations including sterile filtration, filling, lyophilization, and vial capping.
• Execute studies and author technical reports regarding container closure system compatibility.
• Maintain internal specifications for components such as vials, stoppers, seals, and pre-filled syringes.
• Apply engineering principles to the handling of small molecule and large molecule parenterals.

Required Skills

• Experience in pharmaceutical parenteral formulations or drug product sterile process engineering.
• Proficiency in Good Laboratory Practice (GLP) for executing studies and authoring protocols and reports.
• Knowledge of unit operations including filtration, lyophilization, and pooling/mixing.
• Ability to write clear, concise, and error-free technical documentation.
• Bachelor’s degree in Chemical Engineering, Bioengineering, Material Science, or a related scientific field with 4+ years of industry experience.
• Master’s degree in Chemical Engineering, Bioengineering, Material Science, or a related scientific field with 2+ years of industry experience.
• Strong interpersonal and verbal communication skills.

Key Skills

Education

Any Graduate