Process Development Engineer

We are searching for a motivated and enthusiastic individual to join our Chemistry Development team to improve our oligonucleotide manufacturing process and to directly contribute to launching new oligonucleotide products. As a Process Development Engineer at Synthego, you will have direct responsibility for the development of new techniques for synthesis and purification of RNA and DNA from nanomole to millimole scales. Primary goals include scaling manufacturing processes, improving cost and margin, improving quality of oligonucleotide products, and reducing production times. This role will include developing in both a research and clinical environment, as well as transferring technology into the manufacturing lines. With a focus on the successful introduction and adoption of new technologies in operations, this role will collaborate closely with the hardware, software, operations, quality, and product teams.

What You'll Do

• Design, develop, and implement methods to scale oligonucleotide synthesis and purification
• Synthesize, purify and analyze oligonucleotides to specifications, using proprietary and commercial instrumentation
• Analyze data from assays such as UV, chromatograms and mass spectrometry for optimizing experimental conditions and determining root causes of failures
• Work alongside a cross-functional group of Chemists, Engineers, and Scientists to execute developmental processes and collaborate on designed experiments.
• Conduct experimentation using automated instrumentation and liquid handling equipment
• Write development protocols and reports and regularly present findings to interdepartmental stakeholders
• Conduct IQ/OQ/PQ for new instrumentation acquired for development projects
• Practice continuous improvement by contributing ideas and suggestions to new and existing processes
• Generate and maintain records or documents in a detailed and consistent manner
• Assist with Quality data management, including writing new or updating Standard Operating Procedures, Batch Records, and Change Control documents
• Work with vendors to acquire reagents, consumables, or instrumentation as needed for development efforts
• Train others on new or updated processes and procedures

About You

• BS in Chemistry, Chemical Engineering, Bio-engineering or a similar field
• 2-5 years of industry experience within a research/manufacturing/production environment, preferably in a small company/start-up setting
• Direct experience in the synthesis and analysis of oligonucleotide products
• Experience in data analysis with languages such as Python, SQL.
• Understanding of aseptic handling techniques, including liquid handling, pipetting, reagent preparation, and consumables.
• Experience using larger scale instrumentation such as HPLCs, oligonucleotide or peptide synthesizers, tangential flow filtration, and/or liquid handlers.
• Strong desire to work in a fast-paced, collaborative start-up environment
• Demonstrates strong interpersonal and communication skills (both written and oral)
• Demonstrates ability to work independently and as part of a team to curate and execute development projects.

Nice to Have

• Deep knowledge of oligonucleotide chemistry or reagent manufacturing, specifically using fluorophores, quenchers, or other oligonucleotide modifiers
• Familiar with qPCR
• Familiar with fluorescence assays and how to create functional tests for newly developed products
• Familiar with biotechnical instrumentation in aspects such as coding new methods, data analysis pipeline, servicing, etc