Senior Manager – Drug Substance Technology & Engineering
Core
Oversee downstream purification manufacturing support unit operations for clinical and commercial biologics drug substance, leading process engineers in technology transfer, manufacturing execution, and optimization.
Role type
Senior Manager, downstream purification engineering
Builds
cGMP clinical and commercial biologics drug substance
Domain
Biopharmaceutical manufacturing (downstream purification)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Downstream purification processes (harvest, clarification, chromatography, viral filtration, UF/DF, sterile filtration), Process scale-up, Technology transfer, Process validation, Troubleshooting, Complex investigation, cGMP compliance, Statistical analysis, Team leadership, Cross-functional collaboration
Preferred skills
Biotechnology process support in regulated environments, Staff development, Regulatory filings and inspections knowledge, Commercial biopharma manufacturing operations, Analytical methods and product quality attributes
Technologies
Protein A, AEX, CEX, UF/DF, Sterile filtration
Responsibilities
Support development, scale-up, tech transfer, and manufacturing execution of downstream purification processes; Identify and implement process improvements; Resolve technical issues during scale-up and manufacturing; Lead site activities for continuous process verification and optimization; Collaborate with cross-functional teams to drive business process improvements; Ensure safety and compliance of process development activities; Provide support for regulatory filings and CMC activities; Create multi-year technical strategies; Mentor and develop staff.
Seniority
Senior Manager, hands-on IC with leadership responsibilities
