Consultant I

Responsibilities

• Develop and manage integrated CMC project plans and timelines across drug substance, drug product, analytical, quality, and regulatory workstreams
• Coordinate end-to-end clinical supplies operations, including demand forecasting, manufacturing scheduling, and inventory management
• Oversee packaging and labeling activities for investigational products ensuring GMP compliance
• Develop and monitor project budgets, forecasts, and program financials
• Lead project risk management efforts to mitigate issues impacting timelines or quality
• Coordinate cross-functional teams and external partners including CDMOs and CMOs
• Prepare and communicate project status reports and dashboards for clients and internal stakeholders

Requirements

• Bachelor's degree in Life Sciences, Chemistry, Biology, Engineering, Pharmaceutical Sciences, or a related scientific discipline
• Minimum of 5 years of project management experience supporting pharmaceutical development or CMC programs
• Demonstrated experience in clinical supplies management and vendor management
• Proficiency with project management tools such as Microsoft Project
• Strong understanding of pharmaceutical development and CMC activities

Preferred Qualifications

• Advanced degree
• PMP or equivalent project management certification
• Experience supporting regulatory submissions and health authority interactions
• Experience with commercial supply chain operations and serialization
• Exposure to small molecules, biologics, and advanced therapies

About the Company

Syner-G BioPharma Group is a strategic biopharma product development and delivery partner that accelerates breakthrough science and the delivery of life-enhancing therapies to patients.