Senior Project Manager, API Coordination

Role Summary

Senior Project Manager, API Coordination responsible for project management and planning of manufacturing and supply chain activities for products used in phase I-III clinical trials and drug development manufacturing. Works with cross-functional groups including API development, formulation, analytical, QA and other R&D manufacturing sites worldwide.

Responsibilities

• Develop supply chain and operational strategies to assure the pilot plant and project teams meet API and/or drug product delivery requirements. Identify conflicts and resolve issues impacting the schedule, including quality, safety, material or equipment availability.
• Identify project-specific requirements (special commodity needs, packaging and lot distribution) and ensure readiness for manufacturing start.
• Manage raw material and commodity sourcing for pilot plant programs.
• Manage external manufacturing programs for resupply campaigns. Coordinate with third-party manufacturers to support campaigns and manage process orders and shipping.
• Collaborate with the materials manager, program manager, and/or team lead to set procurement expectations. Identify changes in forecast volumes or deliveries that may require changes in purchasing strategy or manufacturing timelines and drive gaps to resolution.
• Collaborate with project teams and commercial operations during product tech transfer to establish expectations and strategies for material transfers and deliveries.
• Responsible for SAP production planning for assigned projects, including BOM maintenance, master recipes, and issuing process orders to warehouse and manufacturing.
• Track and communicate project timelines, activities and logistics. Generate metrics for area KPI reviews.
• Lead process improvement initiatives to streamline supply chain and operational activities for the pilot plant.
• Participate in cross-functional initiatives as needed.

Qualifications

• Bachelor's degree required.
• Minimum 5+ years total experience in the pharmaceutical industry.
• Experience in one of the following areas: Drug development (e.g., process chemistry, formulation), Manufacturing Operations, Supply Chain, or Quality Assurance.
• Understanding of compliance importance in a regulated environment.
• Ability to collaborate across departments/functions and interact tactfully and professionally.
• Ability to manage and prioritize multiple tasks under tight deadlines and high pressure.
• Strong problem-solving and project management skills.
• Strong communication skills (both written and oral).

Skills

• Project management
• Supply chain and procurement
• SAP production planning
• Cross-functional collaboration
• Process improvement

Education

• Bachelor's degree required.