Senior Technical Specialist / Drug Substance required to provide technical support to drug substance projects / technical developments across various CMOs / External Manufacture.
Competent in broad functional capabilities and acts independently in their role.
Initially a 2 year contract Providing technical and scientific direction for ongoing commercial drug substance manufacture at CMOs.
Provide technical direction for the identification and implementation of process optimization initiatives as well as efficiency and capacity improvements at CMOs, using AI tools where applicable.
Provide significant technical depth to support continuous process improvement to maximize yield and lower cost of goods (Co Gs).
Partner with regulatory and quality assurance colleagues to ensure that processes are maintained in a validated and compliant state throughout their lifecycle.
Oversee process monitoring and statistical analysis of commercial external manufacturing activities (continued process verification).
Support the generation and review of CMC sections of the NDA/MAA and other technical documents for regulatory agency submission for commercial CMO sites.
Communicate operational status of CMOs regularly to management, as required, at the appropriate level of detail.
Communication will be both written documents, and in formal and informal oral presentations.
Up to 20% of international travel may be required for this role.
Requirements: Minimum of 5 years experience in a technical or manufacturing role in the pharmaceutical industry with a major focus on drug substance (DS).
High level of technical expertise in DS pharmaceutical manufacturing across multiple processing areas.
Comprehensive understanding of c GMP requirements for clinical and commercial manufacturing.
Broad experience of technology transfer, process validation management, and continuous improvement.
Effective communication skills to enable successful relationships with both internal and external stakeholders.
Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections.
Minimum undergraduate degree in scientific discipline (Biochemistry, Chemistry, Pharmacy), Engineering (Chemical, Mechanical) or related field.
Experience with AI and AI related tools for Continuous improvement projects is desirable.
Skills: Drug substance manufacture