CMC Program Consultant I — Remote/Travel

Syner-G; Boston (MA); On-site; USD 105,000 - 145,000; Full time

Benefits offered by this job

Flexible paid time off

Office locations in Greater Boston

Remote work options

Job summary

Syner-G BioPharma Group is seeking a Consultant I to lead planning and execution of drug substance/product development programs across CMC, coordinating cross-functional teams and external partners from development through commercialization.

The role requires a life sciences degree and 5 years of PM experience in pharma; travel up to 100% to client sites; based in the Greater Boston area. GMP, regulatory, and clinical supplies experience are preferred.

Qualifications

• Bachelor's degree in Life Sciences or related field required.
• Minimum 5 years PM experience supporting pharmaceutical development or CMC programs for Consultant level; 8+ for Senior Consultant.
• Experience managing cross-functional CMC development programs in biotech/pharma/CDMO.
• Experience with clinical supplies management, including supply planning and distribution.

Responsibilities

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

Skills

Project management

Cross-functional leadership

GMP knowledge

Regulatory submissions

Vendor management

Stakeholder communication

Education

Bachelor's degree in Life Sciences or related field

Advanced degree preferred

Tools

Microsoft Project

Job description

Syner-G BioPharma Group is seeking a Consultant I to lead planning and execution of drug substance/product development programs across CMC, coordinating cross-functional teams and external partners from development through commercialization.

The role requires a life sciences degree and 5 years of PM experience in pharma; travel up to 100% to client sites; based in the Greater Boston area. GMP, regulatory, and clinical supplies experience are preferred.