Sr Associate Mfg - Nights
Core
Lead manufacturing operations in the Inoc/Seeds area, performing critical processes, validation, and troubleshooting to produce innovative medicines for patients with serious illnesses.
Role type
Senior Associate Manufacturing Engineer (Bioprocessing)
Builds
Biologics and small-molecule medicines for Oncology, Inflammation, General Medicine, and Rare Disease
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, SOP development and revision, CAPA ownership, Lean transformation, equipment commissioning and qualification, technical writing, basic troubleshooting, process validation, cross-functional collaboration
Preferred skills
Small-scale and wave bioreactor operation, aseptic processing, regulatory knowledge (CFR), mechanical expertise, LIMS usage, statistical analysis, chemistry/biology principles, project management
Technologies
Trackwise, Delta V, RD's, LIMS
Responsibilities
Lead manufacturing operations on the production floor; ensure safety and compliance; participate in equipment commissioning, qualification, and validation; provide troubleshooting and technical support; write and revise controlled documentation; serve as SME for functional area operations; provide training to manufacturing staff; own deviations and CAPA; champion continuous improvement initiatives; collaborate with Quality, Engineering, and Regulatory teams.
Seniority
Senior, hands-on IC