Sr Engineer - Process Development
Core
Develop and deploy oligonucleotide manufacturing processes, execute feasibility builds, and transfer sustainable manufacturing processes to production.
Role type
Senior Process Engineer (Oligonucleotide Manufacturing)
Builds
Oligonucleotide manufacturing processes and production equipment
Domain
Biotechnology / Genomics / Chemical Engineering
Required skills
Oligonucleotide process expertise (synthesis, cleavage, purification, QC), DOE and Statistical Process Control, GMP compliance, Equipment operation (synthesizers, HPLCs, MS), Cross-functional project management
Preferred skills
Liquid handlers, ERP systems, cGMP/21 CFR part 11, High volume production, Product development project management
Technologies
Synthesizers, Preparative HPLCs, Analytical HPLCs, MS, UV Specs, Liquid handlers, ERP systems
Responsibilities
Execute feasibility and development oligonucleotide builds, Ideate and create manufacturing processes, Author procedures and train operators, Troubleshoot yield and quality issues, Construct and execute controlled experiments (DOE), Analyze process test results and author reports, Work cross-functionally on NPI core teams, Ensure successful knowledge transfer to manufacturing
Seniority
Senior, hands-on IC