CMC Strategy Consultant

CMC Strategy Consultant

Position Overview: Our client is seeking an experienced Part-Time CMC (Chemistry, Manufacturing, and Controls) Strategy Consultant to lead the strategic planning and execution of CMC activities for our Phase 3 clinical trials and potential commercial operations in the US and EU. The ideal candidate will possess deep expertise in CMC strategy and a track record of successfully managing integrated timelines, resource planning, cost estimation, and risk management in a pharmaceutical or biotechnology setting. This candidate will be setting the overall strategy and working with their internal team to execute.
Key Responsibilities:

• Strategic Leadership: Develop and oversee the CMC strategy for Phase 3 clinical trials and potential commercialization in the US and EU markets. Ensure alignment with overall program objectives and regulatory requirements.
• Integrated Timeline Management: Create and maintain comprehensive CMC project timelines that integrate various activities, milestones, and deliverables. Monitor progress and make adjustments as needed to ensure timely project execution.
• Resource Planning: Assess and allocate resources effectively to support CMC activities, including coordination with internal teams and external partners. Identify and address gaps.
• Cost Management: Develop and manage budgets related to CMC activities. Provide cost estimates, track expenditures, and identify opportunities for cost savings.
• Risk Assessment: Identify potential risks associated with CMC activities and develop mitigation strategies. Proactively address issues to minimize impact on project timelines and objectives.
• Regulatory Strategy: Support regulatory submissions and interactions with health authorities. Ensure CMC strategy aligns with regulatory requirements and best practices for both US and EU markets.
• Cross-Functional Collaboration: Collaborate with internal teams (e.g., R&D, clinical, regulatory) and external partners (e.g., contract manufacturing organizations, consultants) to ensure successful execution of CMC plans.
• Reporting and Communication: Provide regular updates to senior management and stakeholders on CMC strategy, progress, risks, and key issues. Prepare and present reports as needed.

Qualifications:

• Experience: Minimum of 8-10 years of experience in CMC strategy and management within the pharmaceutical or biotechnology industry. Proven track record in managing complex CMC projects, particularly for late-stage development and commercialization.
• Education: Bachelor’s degree in a relevant scientific or engineering discipline (e.g., Chemistry, Biochemistry, Chemical Engineering). Advanced degree (e.g., Master’s, PhD) preferred.
• Skills: Strong understanding of CMC processes, regulatory requirements, and industry standards. Excellent project management, analytical, and problem-solving skills. Ability to effectively communicate and collaborate with cross-functional teams and external partners.