Vice President – CMC & Technical Operations
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Job Description
Vice President/Senior Director for CMC overseeing strategy and execution at biotechnology company. Leading efforts from Phase 3 through regulatory approval and commercial launch.
Responsibilities:
- Own sponsor-side pharmaceutical CMC strategy and decision-making from Phase 3 through commercial launch
- Serve as the company's single accountable leader for manufacturing strategy, regulatory CMC, commercial readiness, and lifecycle management
- Translate CMC gaps, risks, and regulatory expectations into practical execution plans with clear priorities, timelines, resources, owners, and decision points
- Prepare, review, and maintain clear, technically consistent CMC source documents and submission-ready materials
- Develop CMC strategies for key regulatory meetings and phase-transition decisions
- Lead technology transfer, manufacturing campaign planning, process validation, supply planning, and commercial readiness
- Assess CMC aspects of Business Development assets or potential acquisitions as required
Requirements:
- BS, MS, or PhD in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related scientific discipline
- 15+ years of pharmaceutical or biotechnology industry experience in CMC, pharmaceutical development, technical operations, manufacturing, or related functions
- Demonstrated experience serving as the sponsor-side CMC lead for a late-stage pharmaceutical development program
- Hands-on experience writing, preparing, reviewing, or defending CMC content for regulatory submissions and health authority interactions
- Strong working knowledge of FDA CMC expectations, ICH guidelines, cGMP requirements, pharmaceutical manufacturing, analytical development, stability, specifications, and control strategy
- Demonstrated success working with CDMOs, analytical laboratories, suppliers, consultants, or other external partners
- Proven ability to lead cross-functionally across Regulatory, Quality, Clinical, Manufacturing, Supply Chain, Program Management, and executive stakeholders
Benefits:
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development opportunities
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