Director Of Formulation And Process Development

Overview

• Lead formulation and process development for injectable drug products across diverse modalities and formats.
• Collaborate with internal and external partners to advance drug product development strategies.
• Ensure phase-appropriate development and lifecycle management of portfolio projects.
• Provide expertise in technology transfer and drug product engineering solutions.
• Mentor and develop team members to achieve efficient drug product development.
• Collaborate with cross-functional teams to align product development strategies.
• Contribute to regulatory filings and ensure compliance with industry standards.
• Participate in strategic planning within Product Development and Clinical Supplies.

Key Responsibilities & Duties

• Develop and implement strategies for injectable drug product formulation and process development.
• Lead technology transfer initiatives and provide engineering solutions for manufacturing processes.
• Ensure compliance with regulatory guidelines and contribute to submission documentation.
• Collaborate with cross-functional teams to optimize drug product development strategies.
• Mentor and manage a team of scientists and engineers in a matrix environment.
• Oversee lifecycle development opportunities and manage project budgets effectively.
• Provide subject matter expertise for regulatory inspections and audits.
• Develop drug product technology roadmaps and manage strategic investments.

Job Requirements

• Doctorate in Bio/Chemical Engineering, Pharmaceutical Sciences, Biochemistry, or related field.
• Minimum of 8 years of experience in drug product development for injectable modalities.
• Proficiency in formulation and process development, regulatory requirements, and manufacturing processes.
• Experience managing teams in a matrix environment and fostering career growth.
• Knowledge of high-concentration protein formulations and aseptic processes.
• Familiarity with vial, prefilled syringe, and cartridge presentations.
• Understanding of cGMP requirements and current regulatory guidelines.
• Strong collaboration skills with cross-functional teams and external partners.