Associate Director, External Manufacturing - Biologics

Role Summary

Associate Director, External Manufacturing - Biologics. Manage third party manufacturing relationships to ensure high-quality product supply in compliance with regulations, on schedule, and within cost targets. Lead cross-functional programs and coordinate operations for existing and new products with suppliers.

Responsibilities

• Participate in the negotiation of the Manufacturing Service Agreement and amendments, and ensure compliance with the terms of the agreements.
• Ensure effective planning and material procurement strategies are in place to supply the TPM with the required materials.
• Communicate to the TPM the product forecasts, and agree on manufacturing and delivery schedules. In coordination with Supply Chain and Planning, ensure the supplier delivers the product according to the demand forecasted.
• Actively participate in the development of Financial Operating Plan, Updates, LRP, and Standard processes, and ensure the financial goals are met
• Coordinate the Steering Committee and monitor that the Virtual Operation Teams meet periodically to evaluate performance, address issues, and if necessary escalate.
• Review status reports and prepare updates for Senior leadership.
• In collaboration with technical and quality teams, periodically review process performance, quality trends, and agree on process improvement plans.
• Establish governance, guidelines, and communication channels. Ensure in coordination with the quality units that the supplier has the required quality systems and documentation to meet regulatory requirements, follow up inspection responses and commitments.
• Coordinate with QA, the annual quality management review and periodic audits of the TPM. Ensure deviations are properly investigated and product disposition decisions are made in a timely manner. Establish performance metrics and periodically track performance.
• Develop, implement and manage the programs or projects such as scope, cost, time & resource management, communication and risk management through the initiating, planning and executing phases of the project.

Qualifications

• Bachelor‚Äôs Degree, preferably in science or technical related field. MSc or MBA degree is preferred.
• A minimum of 10+ years of experience, in areas such as: manufacturing, engineering, project management, quality and S&T.
• The individual needs a broad business perspective, knowledge and understanding of manufacturing processes.
• Strong project experience and an ability to influence others are essential.
• Previous experience managing subcontracted relationships preferred.
• Proven leadership ability with superior communication skills including listening, verbal, presentation and written.
• Strong strategy development and planning skills coupled with necessary knowledge of pharmaceutical development, manufacturing and supply activities.
• Issue identification and strong problem analysis and solution development skills.
• Demonstrated team player and ability to work in a globally oriented work environment.
• Strong knowledge of business financial systems and tools

Skills

• Program management
• Supply chain coordination
• Quality systems and regulatory compliance
• Strategic planning and forecasting
• Stakeholder management and cross-functional leadership
• Financial planning and budgeting

Education

• Bachelor‚Äôs Degree in science or technical field; MSc or MBA preferred

Additional Requirements

• None beyond standard travel/availability expectations described in the role (not specified in source)