Assoc. Director, Drug Substance Commercialisation
Core
Lead process development, scale-up, and technical support for the introduction and production of clinical and commercial active pharmaceutical ingredients (APIs) at a commercial manufacturing hub.
Role type
Senior IC process chemistry and engineering leader (commercialisation)
Builds
Clinical and commercial APIs for patient healthcare needs
Domain
Pharmaceutical manufacturing / Chemistry / Chemical Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process chemistry, Process development, Scale-up, GMP compliance, Deviation management, Batch record review, Process validation, Equipment qualification, Change control, Project management
Preferred skills
CMC considerations, New product development, Supply chain connectivity, Strategic thinking, Lean leadership
Technologies
DeltaV, Electronic batch records
Responsibilities
Lead technical support for commercialisation activities across clinical and commercial production; Oversee evaluation of raw materials, process fits, and optimisation of chemical API routes; Provide process leadership to production campaigns (pre-PPQ and commercial); Manage transfers of processes to other company sites or external partners; Develop and coach team members; Ensure assigned processes and systems comply with site, divisional, and corporate quality standards.
Seniority
Senior, hands-on IC with people and project management responsibilities
