Manager, Technical Operations
Core
Manage and coach production staff to ensure commercial viability of manufacturing processes for microbial fermentation, synthetic small molecules, and sterile filling.
Role type
Manager, Technical Operations (Manufacturing)
Builds
Clinical-to-commercial scale production of active pharmaceutical ingredients (APIs) and drug products
Domain
Biopharmaceutical manufacturing / Advanced Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Production staff management, process supervision, technical transfer, SOP development, risk assessment, process alignment, client communication
Preferred skills
API and drug product manufacturing, Manufacturing Operations, Supply Chain, Quality Assurance, Validation, Quality Control, Process Analytic Technology (PAT)
Technologies
Process Analytic Technology (PAT)
Responsibilities
Manage, train, and coach a team of production staff; Conduct routine direct floor level supervision and coaching; Facilitate alignment of Development and Operations technical decisions for process performance and validation runs; Provide technical guidance to Sales and Marketing for new project evaluation; Assess risks in the technical transfer process; Develop and approve process SOPs and training documents; Communicate information to ensure successful product transfer and commercialization; Participate in client visits and project inception to completion
Seniority
Manager, hands-on leadership
