Sr Engineer - Process Development

Responsibilities: Execute feasibility and development oligonucleotide builds for project timelines Design manufacturing processes and specify technical requirements for new production equipment Author procedures and train operators for GMP production Troubleshoot yield, quality and throughput issues in new products Run controlled experiments (DOE) to optimize processes and scale for production Analyze test results and recommend quality improvements Collaborate with Product Development, Supply Chain, Manufacturing, Quality, EHS and Facilities on NPI core teams Ensure knowledge transfer to manufacturing and sustaining support teams

Key requirements: Expertise with oligonucleotide processes (synthesis, cleavage/deprotection, purification, desalting, QC) and equipment (synthesizers, preparative HPLCs, analytical HPLCs, MSs, UV specs) Experience with liquid handlers and ERP systems is a plus Ability to work across departments to meet goals Strong verbal and written communication and organizational skills Expertise with Statistics, SPC and DOE techniques Experience with cGMP and 21 CFR part 11 in FDA-regulated environment is preferred Experience with high-volume production in a high-tech consumables industry is a plus Experience with product development processes and project management is a plus cross-functional collaboration problem-solving effective communication oligonucleotide synthesis and processing HPLC (preparative/analytical) mass spectrometry (MS)