Senior Project Manager, API Coordination

Role Summary

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

Responsibilities

• Develop supply chain and operational strategies to ensure pilot plant and project teams meet API and/or drug product delivery requirements. Identify conflicts and resolve issues that may impact the schedule, including quality, safety, material or equipment availability.
• Identify project-specific requirements (e.g., special commodity needs, packaging and lot distribution) and ensure readiness for manufacturing start.
• Oversee raw material and commodity sourcing of 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. Detect significant changes in forecast volumes or deliveries that may require changes in purchasing strategy or manufacturing timelines; drive gaps to resolution.
• Coordinate 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 warehousing and manufacturing.
• Track and communicate project timelines, activities and logistics; generate metrics for 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 of 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 the importance of compliance in a regulated environment.
• Ability to work collaboratively across departments/functions and interact in a tactful, professional manner.
• Ability to manage and prioritize multiple tasks under tight deadlines and high pressure.
• Strong problem solving and project management skills.
• Strong communication skills (written and oral).