CMC Program Lead — Remote Biopharma Consulting

Syner-G BioPharma Group; Boston, Northern (MA, KY); Hybrid; USD 120,000 - 150,000; Full time

Job summary

Syner-G BioPharma Group seeks a Consultant I to support planning and execution of drug substance and drug product development across a diverse client portfolio. This client-facing role serves as the operational lead for CMC programs, coordinating manufacturing, analytical, quality, regulatory, and supply chain activities from early development through commercialization.

Travel to client sites may be required up to 100%, based on project demands.

Qualifications

• Bachelor's degree in Life Sciences, Chemistry, Biology, Engineering, Pharmaceutical Sciences, or related field.
• Minimum of 5 years project management experience supporting pharmaceutical development or CMC programs (Consultant Level).
• Minimum of 8 years project management experience supporting pharmaceutical development or CMC programs (Senior Consultant Level).
• Experience managing cross-functional CMC development programs within biotech/pharma/CDMO/consulting.
• Experience with clinical supplies management, including supply planning, packaging, labeling, inventory management, and clinical trial distribution.
• Proficiency with project management tools and software, including Microsoft Project.

Responsibilities

• Develop and manage integrated CMC project plans and timelines across drug substance, drug product, analytical, quality, and regulatory workstreams.
• Identify project dependencies, milestones, critical path activities, and resource requirements to ensure successful program execution.
• Coordinate end-to-end clinical supplies operations, including demand forecasting, manufacturing scheduling, packaging, labeling, release, distribution planning, and inventory management.
• Oversee packaging and labeling activities for investigational products, ensuring GMP compliance and regulatory requirements.
• Develop and monitor project budgets, forecasts, and program financials, including vendor invoice review and change order administration.
• Lead project risk management efforts by identifying, tracking, mitigating, and escalating risks and issues.
• Coordinate cross-functional teams and external partners, including CDMOs, CMOs, laboratories, and specialty service providers.
• Facilitate team meetings, governance reviews, and client status meetings, documenting decisions and action items.
• Prepare and communicate project status reports, dashboards, and milestone reviews for clients and internal stakeholders.
• Build and maintain strong client relationships as a trusted project management partner.
• Support business development through scope definition and proposal support.

Skills

Project management

Communication skills

Risk management

Cross-functional coordination

Problem solving

Education

Bachelor's degree in Life Sciences

Advanced degree preferred

Tools

Microsoft Project

Job description

Syner-G BioPharma Group seeks a Consultant I to support planning and execution of drug substance and drug product development across a diverse client portfolio. This client-facing role serves as the operational lead for CMC programs, coordinating manufacturing, analytical, quality, regulatory, and supply chain activities from early development through commercialization.

Travel to client sites may be required up to 100%, based on project demands.