Manufacturing Product Lead
Core
Provide technical support for oral solid dose process manufacturing, including process improvements, technology transfer, investigations, and troubleshooting.
Role type
Senior Manufacturing Product Lead
Builds
Commercial oral solid dose drug products
Domain
Pharmaceutical manufacturing (oral solid dosage forms)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, process optimization, technology transfer, batch record authoring, root cause analysis, continuous improvement, regulatory inspection support, change control management
Preferred skills
Lean Manufacturing, Six Sigma, Operational Excellence, equipment IQ/OQ/PQ validation
Technologies
Microsoft Office
Responsibilities
Collaborate with cross-functional teams to optimize productivity and supply reliability; Author and approve master batch records and equipment recipes; Partner with commercial clients on technical issues; Execute continuous improvement projects to reduce cost and enhance safety; Lead technology transfer of new processes from R&D to commercial sites; Serve as subject matter expert during internal audits and regulatory inspections
Seniority
Senior, hands-on IC with leadership responsibilities