Manufacturing Specialist
Core
Technical owner and shopfloor leader for biologics manufacturing units (API, mAb, Conjugation, Aseptic Filling, Secondary Packaging) ensuring safe, compliant, and efficient operations from startup to commercial production.
Role type
Manufacturing Specialist (Hands-on IC)
Builds
Antibody-Drug Conjugate (ADC) biologics and small/large molecule pharmaceuticals
Domain
Biopharma / Biologics Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Equipment lifecycle management, GMP compliance, equipment troubleshooting, validation support (FAT/SAT/IQ/OQ/PQ), SOP development, batch record management, risk assessment, cross-functional collaboration, continuous improvement (Lean), single-use system management
Preferred skills
New facility startup experience, ADC/high containment/aseptic filling expertise, automated process equipment familiarity, manufacturing investigations, EU GMP Annex 01 knowledge, reliability improvement tools
Technologies
DCS, MES, Single-use systems, Automated process equipment
Responsibilities
Serve as technical owner for assigned manufacturing unit ensuring equipment readiness; Plan and support FAT, SAT, commissioning, qualification, and validation activities; Provide rapid troubleshooting and breakdown investigations for equipment; Drive SOP development, batch record inputs, and operator training; Ensure alignment between DCS recipes and MES master batch records; Participate in risk assessments and support deviations, CAPAs, and change controls; Coordinate with Engineering, QA, Validation, and Supply Chain for production support and new product introductions
Seniority
Mid-Senior, hands-on IC
