Manufacturing Sciences and Technology (MS&T) Engineer III
Core
Lead MS&T team to coordinate technical process development and transfer for clinical supply manufacturing and packaging operations, ensuring compliance with cGMP and driving continuous improvement.
Role type
Senior IC Manufacturing Sciences and Technology Engineer (Team Lead)
Builds
Clinical supply manufacturing processes, packaging solutions, and technical documentation for pharmaceutical clients.
Domain
Pharmaceutical manufacturing / Clinical supply chain
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP equipment operation, tech transfer execution, deviation/change control management, root cause analysis, SOP authoring, batch record management, cross-functional project leadership, data trend analysis, risk assessment (FMEA/Hazard Analysis), staff hiring and training
Preferred skills
Packaging Engineering background, Artios CAD, TOPS Pro, TrackWise, ComplianceWire, project management, customer service
Technologies
Microsoft Office (Word, PowerPoint, Excel, Visio), TOPS Pro, TrackWise, ComplianceWire, Artios CAD
Responsibilities
Lead MS&T team to coordinate projects ensuring correct technical requirements documentation generated, monitored and drive successful adherence and completion; Works cross functionally with project managers, production, label design and control, quality assurance, quality control, supply chain, and facilities departments to effectively transfer and maintain processes in the facility; Leads the compilation of process data, including communicating project status, and delivering internal and client presentations; Collects and trend process data for external (Clients) and internal review to ensure process consistency; Provides business case for process improvement projects; Authors and reviews technical reports, source documents, SupplyFlex records, legacy records, master batch records, product and equipment specifications, protocols and any other technical documents not listed in support of tech transfer and cGMP activities; Acts as the lead for technical support deviations, change controls, and CAPAs including determination of event impact, root-cause analysis, and corrective action identification; Responsible for maintaining a high performing team by hiring, training, motivating, evaluating, and developing staff; Drive departmental training; Author and regularly review Standing Operating Procedures relating to your own areas of responsibility
Seniority
Senior, hands-on IC with team leadership responsibilities
