Upstream Process Development Lead
Core
Lead upstream process development for mammalian cell culture and microbial fermentation platforms to support recombinant protein and vaccine antigen production.
Role type
Senior IC upstream process development lead (bioprocess)
Builds
Scalable, GMP-compliant upstream processes for vaccine and therapeutic protein manufacturing
Domain
Biopharmaceuticals / Vaccine development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Upstream bioprocess development, Mammalian cell culture, Microbial fermentation, Bioreactor operation (ambr, stirred-tank, rocking-motion), DOE, Process modeling, Scale-up, Technology transfer, GMP manufacturing, Cell line evaluation, Media/feed optimization
Preferred skills
Quality by Design (QbD), Process characterization, Scale-down models, Continuous processing, Advanced process monitoring, CMC drug-substance development, Downstream purification, Protein chemistry, Data modeling and automation
Technologies
ambr, stirred-tank bioreactors, rocking-motion bioreactors, perfusion systems, fixed-bed bioreactors
Responsibilities
Provide scientific and people leadership for upstream process development workstreams; Design and execute complex studies to improve cell growth, protein expression, yield, and quality; Optimize hosts, cell lines, inoculum strategies, media, and bioreactor parameters; Lead scale-up and technology transfer activities; Evaluate and implement new upstream technologies; Translate experimental results into process decisions and risk assessments.
Seniority
Senior, hands-on IC with leadership responsibilities
