This role will provide technical oversight for our external manufacturing partners which encompasses drug substance and intermediate manufacturing. The Technical Lead will serve as the primary technical interface between the company and its contract manufacturing organizations (CMOs/CDMOs), ensuring manufacturing processes remain robust, reproducible, compliant, and capable of consistently delivering product that meet established quality and supply requirements.
The incumbent will provide end-to-end technical stewardship of externally manufactured processes and work cross functionally with Quality, Regulatory, External Manufacturing, Supply Chain and Procurement.
Responsibilities
- Serve as the primary technical representative to external manufacturing partners for assigned products and processes.
- Maintain detailed understanding of manufacturing processes, critical process parameters, critical quality attributes, process controls, equipment capabilities and process performance.
- Review manufacturing performance and identify process trends, risks, variability, and opportunities for improvement.
- Provide technical leadership for manufacturing deviations, investigations, root-cause analysis, CAPAs, and process related troubleshooting.
- Asses the technical impact of manufacturing changes, including equipment, raw materials, process parameters, scale, facilities, and manufacturing strategy.
- Lead or support technology transfers, process scale-up, process validation (PPQ), continued process verification (CPV), and introduction of processes to new manufacturing sites.
- Provide technical input to change controls, regulatory submissions, validation strategies, comparability assessments, and product lifecycle management.
- Partner with Quality to ensure external manufacturing operations maintain appropriate technical and GMP standards.
- Work with Supply Chain and External Manufacturing to identify and mitigate technical risks that could affect product supply.
- Lead technical governance discussions with CMOs/CDMOs and ensure technical issues are appropriately escalated and resolved.
- Develop and monitor process performance metrics and communicate manufacturing performance, technical risks, and improvement opportunities to internal stakeholders.
- Drive process robustness, manufacturing efficiency, yield improvement, cycle-time reduction, and other continuous improvement initiatives.
- Support regulatory inspections and health-authority inquiries related to externally manufactured drug substances.
- Make significant contributions to project team through lab based, or other work environments, activities, as needed.