Associate Director, Drug Substance Manufacturing – Upstream Process
Core
Lead upstream biologics manufacturing operations for outsourced CMOs, overseeing technology transfer, process validation, and lifecycle management for monoclonal antibodies and recombinant therapeutics.
Role type
Senior IC manufacturing operations leader (upstream biologics)
Builds
Commercial biologic drug substances (monoclonal antibodies, recombinant therapeutics)
Domain
Biotechnology / Biologics Manufacturing
Required skills
Upstream process expertise (cell culture, expansion, harvest), Technology transfer management, Process validation, CMO oversight, GMP compliance, Statistical analysis for CPV, Regulatory submission authoring (CMC sections), Cross-functional program leadership
Preferred skills
MSAT (Manufacturing Sciences and Technology) experience, Big data modelling tools proficiency
Technologies
MS Project, Big data modelling tools
Responsibilities
Serve as primary technical interface with global CMOs for upstream activities; Lead investigations for technical deviations and CAPA implementation; Oversee technology transfer and process qualification across CMO sites; Author and review validation protocols and CMC regulatory submissions; Perform statistical analysis for Continuous Process Verification (CPV) and process trends; Manage timelines, supply impact, risks, and budgets for manufacturing campaigns.
Seniority
Senior, hands-on IC with leadership responsibilities
