Job Summary: The Associate Director of Manufacturing will oversee the end-to-end manufacturing process for our vaccine products, ensuring compliance with regulatory standards and optimizing collaboration with CDMOs. The ideal candidate will have extensive experience in pharmaceutical manufacturing, particularly in vaccine production, and a proven track record of managing CDMO relationships.

Key Responsibilities:

Manufacturing Oversight:

• Lead and manage all aspects of vaccine manufacturing operations, from raw material procurement to final product release.
• Ensure production processes comply with Good Manufacturing Practices (GMP) and regulatory requirements.
• Monitor and evaluate manufacturing performance, implementing continuous improvement initiatives.

CDMO Management:

• Develop and maintain strong relationships with CDMOs, ensuring alignment with company goals and timelines.
• Oversee CDMO contracts, negotiations, and performance to ensure high-quality and cost-effective manufacturing services.
• Coordinate with CDMOs to resolve any production issues and ensure timely delivery of vaccine products.

Team Leadership:

• Lead and mentor a team of manufacturing professionals, fostering a collaborative and high-performing work environment.
• Conduct performance reviews and provide ongoing training and development opportunities for team members.
• Collaborate with cross-functional teams to support project goals and timelines.

Regulatory Compliance:

• Ensure all manufacturing activities comply with FDA, EMA, and other relevant regulatory agencies.
• Prepare and review documentation required for regulatory submissions and audits.
• Stay updated on industry regulations and standards to ensure ongoing compliance.

Process Development and Optimization:

• Identify and implement process improvements to enhance manufacturing efficiency and product quality.
• Work with R&D and Quality Assurance teams to transfer new vaccine products from development to commercial manufacturing.
• Utilize data and analytics to drive decision-making and process optimization.

Financial Management:

• Develop and manage the manufacturing budget, ensuring cost control and resource optimization.
• Analyze production costs and implement strategies to improve cost-efficiency.
• Prepare financial reports and forecasts related to manufacturing operations.

Qualifications:

• Bachelor’s degree in Chemical Engineering, Biotechnology, Pharmaceutical Sciences, or a related field. Advanced degree (MBA, MS, PhD) preferred.
• Minimum of 10 years of experience in pharmaceutical manufacturing, with at least 5 years in a leadership role.
• Extensive experience in vaccine manufacturing and working with CDMOs.
• In-depth knowledge of GMP, FDA, EMA, and other regulatory requirements.
• Proven ability to manage complex manufacturing projects and lead cross-functional teams.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent communication and interpersonal skills.
• Proficiency in manufacturing software and data analysis tools.
• Ability to travel as needed to CDMO sites and other company locations.