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
Company Overview