Process Specialist (Technology Transfer) - Eurofins CDMO Alphora, Inc.
Core
Bridge R&D, Operations, and clients to design, implement, and support safe, scalable, compliant manufacturing processes for complex APIs from development to full-scale GMP production.
Role type
Early-career Process Specialist (Technology Transfer)
Builds
Safe, scalable chemical manufacturing processes for complex Active Pharmaceutical Ingredients (APIs)
Domain
Pharmaceutical manufacturing / Contract Development and Manufacturing Organization (CDMO)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (manufacturing execution)
Required skills
Process scale-up, Master Batch Record generation, Production Batch Record execution, Batch execution support, Material readiness coordination, Campaign reporting, cGMP compliance, EHS adherence, Deviation management
Preferred skills
Chemistry/Chemical Engineering background, regulated environment experience, problem-solving, cross-functional collaboration
Technologies
cGMP facilities, batch scheduling tools, tracking tools, SOPs
Responsibilities
Collaborate with R&D, QC, QA, and Operations to design processes from gram to multi-kilogram scale; Generate and review Master and Production Batch Records; Provide on-the-floor technical support during manufacturing campaigns; Coordinate material readiness and bills of materials; Represent Operations in client and internal meetings; Uphold cGMP, EHS, and documentation standards; Provide after-hours on-call support for processing issues.
Seniority
Early-career, hands-on IC
