Senior Manager – Drug Substance Technology & Engineering
$148,715–$201,203 year
On-site · Thousand Oaks, California, United States
Job Summary
Senior Manager – Drug Substance Technology & Engineering role focused on leading downstream purification development for biologics in a cGMP environment. Responsible for scale-up, tech transfer, and manufacturing execution of downstream processes (harvest, clarification, chromatography including Protein A, AEX, CEX, viral filtration, UF/DF, sterile filtration) and for driving process improvements, problem-solving during scale-up, and ensuring product quality attributes. Collaborates with Process Development, Quality, Manufacturing, Regulatory, Validation, and Supply Chain to support continuous improvements, regulatory filings, and lifecycle management. Leads a cross-functional team of downstream process engineers, provides technical leadership, mentorship, and development of staff, and aligns manufacturing operations with registered processes while supporting site-wide strategic initiatives and leadership activities.
Required Qualifications
- Doctorate degree in a relevant field and 2 years of biologics process development or commercial-scale technical support experience OR Master’s degree and 6 years of biologics process development or commercial-scale technical support experience OR Bachelor’s degree and 8 years of biologics process development or commercial-scale technical support experience OR Associate’s degree and 10 years of biologics process development or commercial-scale technical support experience OR High school diploma / GED and 12 years of biologics process development or commercial-scale technical support experience
- Minimum of 2 years directly managing people and/or leadership experience leading teams, projects, programs, or directing allocation of resources
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