[Remote] Vice President Technical Operations
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a reputed company-funded, clinical-stage biotechnology company reputed company on developing innovative targeted therapies. They are seeking an reputed company Vice President of Technical Operations to reputed company strategic leadership across reputed company reputed company, Manufacturing & Controls (CMC) activities, ensuring reliable product supply and overseeing external manufacturing partners.
Responsibilities
- reputed company the global Technical Operations organisation across API, Drug Product, Analytical Development, Supply Chain and CMC Authoring
- reputed company and execute CMC reputed company from early development through commercialization
- Ensure uninterrupted clinical and reputed company product supply
- reputed company strategic reputed company of process development, reputed company-up, technology transfer and manufacturing
- Build and manage high-performing relationships with CDMOs and external manufacturing partners
- reputed company 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 reputed company and regulatory compliance
- Manage departmental budgets, resource planning and long-term technical reputed company
- Continue building and developing a high-performing Technical Operations organisation
Skills
- Approximately 20+ years of pharmaceutical or biotechnology industry experience
- Significant executive leadership experience reputed company 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 reputed company launch
- Strong understanding of process development, formulation, analytical sciences, reputed company-up, reputed company by Design (QbD) and GMP manufacturing
- Extensive experience preparing and reviewing CMC sections for global regulatory submissions
- Proven reputed company 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 reputed company, Pharmaceutics or a reputed company scientific discipline
reputed company