MSAT Drug Product Lead (Associate Director level)
Core
Lead MSAT drug product technical delivery for NPI and product launches, ensuring robust product control strategies and right-first-time qualifications.
Role type
Associate Director, MSAT Drug Product Lead
Builds
Drug product manufacturing processes and qualified product families
Domain
Pharmaceutical manufacturing (oral solid dose)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (manufacturing process qualification and validation)
Required skills
Technology transfer leadership, process validation, GMP compliance, risk assessment, product control strategy definition, cross-functional investigation management, regulatory dossier support, oral solid dose manufacturing expertise
Preferred skills
Advanced degree (MSc/PhD), Quality by Design implementation, statistical process control, complex technical investigation leadership, regulatory filing support, operational improvement project leadership
Technologies
GMP, QbD, SPC
Responsibilities
Act as single technical point of contact for drug product portfolio; lead technology transfers to internal and external sites; manage continued process verification and change management; drive right-first-time product qualification execution; define and maintain product control strategies; support regulatory submissions and inspections; manage cross-functional investigations for deviations.
Seniority
Associate Director, hands-on IC with strategic oversight
