Senior Consultant, Chemistry, Manufacturing, and Controls (CMC)

POSITION OVERVIEW

Syner-G is seeking an experienced Senior Consultant to serve as a strategic Chemistry, Manufacturing, and Controls (CMC) leader supporting pharmaceutical and biotechnology clients through all phases of drug development. This individual will act as a trusted advisor, providing technical leadership, strategic guidance, and hands-on execution across CMC development programs for biologics, and cell and gene therapy products.

The ideal candidate will possess extensive experience in drug substance and drug product development, regulatory strategy, technical operations, and CMC program leadership. This role requires exceptional communication skills, the ability to influence cross-functional teams and external partners, and a proven track record of successfully advancing development programs from early-stage development through commercialization.

The successful candidate will operate independently while partnering closely with clients, Contract Development and Manufacturing Organizations (CDMOs/CMOs), regulatory agencies, and internal teams to ensure successful program execution and delivery of high-quality outcomes.

KEY RESPONSIBILITIES

• Serve as a trusted CMC advisor to clients, providing strategic guidance across all phases of product development.
• Lead and manage CMC development activities for drug substances and drug products, ensuring alignment with program objectives and regulatory requirements.
• Oversee CDMO/CMO selection, qualification, contracting, and ongoing management to support development and manufacturing activities.
• Develop and maintain strong client relationships while serving as the primary technical point of contact for assigned programs.
• Provide technical leadership and strategic oversight for analytical development, process development, technology transfer, manufacturing, and product characterization activities.
• Review, author, and provide final approval of CMC-related regulatory documents and submissions supporting clinical trials and commercial programs globally.
• Collaborate with cross-functional teams, including Regulatory Affairs, Quality, Nonclinical, Clinical, Manufacturing, and Supply Chain stakeholders.
• Identify program risks, develop mitigation strategies, and proactively resolve technical and operational challenges.
• Facilitate decision-making processes and provide recommendations based on scientific, technical, regulatory, and business considerations.
• Support project planning, execution, timeline management, and milestone tracking to ensure successful program delivery.
• Participate in business development activities, proposal development, client presentations, and marketing initiatives.
• Mentor junior consultants and contribute to the continued growth of Syner-G's technical capabilities and consulting excellence.