Senior Consultant

Responsibilities

• Serve as a strategic CMC advisor to clients across all phases of product development
• Lead and manage CMC development activities for drug substances and drug products
• Oversee CDMO/CMO selection, qualification, contracting, and ongoing management
• Provide technical leadership for analytical development, process development, and technology transfer
• Review and author CMC-related regulatory documents and submissions for global clinical and commercial programs
• Collaborate with cross-functional teams including Regulatory Affairs, Quality, and Clinical
• Identify program risks and develop mitigation strategies
• Participate in business development, proposal development, and client presentations
• Mentor junior consultants to support technical capability growth

Requirements

• Bachelor's degree in Chemistry, Pharmaceutical Sciences, Biology, Chemical Engineering, or Life Sciences
• 15+ years of experience in Pharmaceutical, Biopharmaceutical, Biotechnology, or Cell and Gene Therapy industries
• Extensive expertise across the full CMC lifecycle
• Demonstrated experience leading CMC strategy and technical operations
• Proven experience managing CDMO/CMO relationships

Preferred Qualifications

• Advanced degree (M.S., Ph.D., or Pharm.D.)

About the Company

Syner-G is a strategic biopharma product development and delivery partner. We support organizations from the critical phases of drug discovery and approval through to commercialization, helping to accelerate breakthrough science and life-enhancing therapies.