Associate Director, External Manufacturing - Small Molecule

Role Summary

The Associate Director, Third Party Manufacturing (TPM) Manager will be the main supplier relationship contact responsible for providing organization, supervision, strategic initiatives, and technical support to manage supply of designated products. The role ensures high quality product is manufactured in compliance with regulations and released/delivered according to forecasts, schedules, and cost plans. This position also manages projects and programs to ensure a cost effective, marketable, and manufacturable product and maximizes profitability throughout its life cycle. Through matrix management of cross functional groups, the Associate Director, TPM leads teams without direct authority and coordinates operations for existing and new products manufactured with the supplier.

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 product forecasts to the TPM and agree on manufacturing and delivery schedules; coordinate with Supply Chain and Planning to ensure delivery according to demand.
• Participate in development of Financial Operating Plan, Updates, LRP, and Standard processes; ensure financial goals are met.
• Coordinate the Steering Committee and monitor Virtual Operation Teams to evaluate performance, address issues, and escalate as needed.
• Review status reports and prepare updates for Senior leadership.
• Collaborate with technical and quality teams to review process performance and quality trends; agree on improvement plans.
• Establish governance, guidelines, and communication channels; ensure the supplier maintains quality systems and documentation to meet regulatory requirements, and follow up on inspection responses and commitments.
• Coordinate with QA on annual quality management reviews and periodic audits of the TPM; ensure deviations are investigated and product disposition decisions are timely; establish metrics and track performance.
• Develop, implement and manage programs/projects including scope, cost, time, resource management, communication, and risk management through initiating, planning, and executing phases.

Qualifications

• Bachelor‚Äôs Degree, preferably in science or technical related field. MSc or MBA preferred.
• 10+ years of experience in manufacturing, engineering, project management, quality, and S&T.
• Broad business perspective with knowledge of manufacturing processes.
• Strong project management experience and ability to influence others.
• Experience managing subcontracted relationships preferred.
• Proven leadership with excellent communication skills (listening, verbal, presentation, written).
• Strong strategy development and planning skills with knowledge of pharmaceutical development, manufacturing, and supply activities.
• Strong issue identification, problem analysis, and solution development skills.
• Collaborative team player with ability to work in a globally oriented environment.
• Strong knowledge of business financial systems and tools.

Skills

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

Education

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

Additional Requirements

• No specific travel requirements stated.