Note: The job is a remote job and is open to candidates in USA. Skills Alliance is a well-funded, clinical-stage biotechnology company focused on developing innovative targeted therapies. They are seeking an experienced Vice President of Technical Operations to provide strategic leadership across all Chemistry, Manufacturing & Controls (CMC) activities, ensuring reliable product supply and overseeing external manufacturing partners.

Responsibilities

• Lead the global Technical Operations organisation across API, Drug Product, Analytical Development, Supply Chain and CMC Authoring
• Develop and execute CMC strategy from early development through commercialization
• Ensure uninterrupted clinical and commercial product supply
• Provide strategic oversight of process development, scale-up, technology transfer and manufacturing
• Build and manage high-performing relationships with CDMOs and external manufacturing partners
• Lead preparation and review of CMC documentation for INDs, IMPDs, NDAs and MAAs
• Represent the CMC function during interactions with global regulatory agencies, including FDA and EMA
• Partner with cross-functional stakeholders to accelerate development timelines while maintaining quality and regulatory compliance
• Manage departmental budgets, resource planning and long-term technical strategy
• Continue building and developing a high-performing Technical Operations organisation

Skills

• Approximately 20+ years of pharmaceutical or biotechnology industry experience
• Significant executive leadership experience within Technical Operations and CMC, ideally in a small to mid-sized biotechnology environment
• Deep expertise across API, Drug Product, Analytical Development and pharmaceutical manufacturing
• Demonstrated experience progressing small molecule products from discovery through commercial launch
• Strong understanding of process development, formulation, analytical sciences, scale-up, Quality by Design (QbD) and GMP manufacturing
• Extensive experience preparing and reviewing CMC sections for global regulatory submissions
• Proven success leading regulatory interactions with agencies such as the FDA and EMA
• Outstanding leadership, strategic thinking and cross-functional collaboration skills
• A PhD (or equivalent experience) in Chemistry, Pharmaceutics or a related scientific discipline

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