Senior CMC Development Consultant
Job Summary
Leading the design and development of a comprehensive Product Development Roadmap, the part-time Senior CMC Product Development Strategy Consultant will create a governance playbook to standardize product development activities from pre-clinical through marketing application readiness, working primarily remotely with occasional onsite workshops.
Key responsibilities
- Lead the design of a comprehensive Product Development Roadmap (PDR) framework covering all stages of product development
- Develop an enterprise playbook defining stage gates, governance models, key activities, and required deliverables
- Facilitate workshops with senior leadership to align on roadmap structure and governance approach
Required qualifications
- 15+ years of progressive experience in pharmaceutical or biotechnology sectors
- Significant leadership experience in CMC Development, Pharmaceutical Development, or Technical Operations
- Experience with stage-gate processes and product development frameworks
- Strong understanding of the CMC development lifecycle and regulatory submission requirements
- Experience facilitating executive workshops and achieving cross-functional alignment
Complete Job Description
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