Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of RNA-targeting modalities including RNAi silencing and RNA editing provides us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Our diversified pipeline is focused on our obesity, alpha-1 antitrypsin deficiency and PNPLA3 I148M liver disease programs and includes clinical programs for Duchenne muscular dystrophy and Huntington’s disease, as well as several preclinical programs utilizing our versatile RNA medicines platform. Driven by the calling to “Reimagine Possible”, we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease.

Description

Wave Life Sciences is seeking a self-motivated Scientist II/Sr. Scientist I, Process Technology Services, CMC to join its Oligonucleotide CMC and Process Development team in Lexington, Massachusetts. The successful candidate will be responsible for the synthesis, purification, Tangential Flow Filtration (TFF), lyophilization, analysis and characterization of oligonucleotides. This position will support CMC activities in multiple programs including external technology transfer and post-tech transfer CMC development and improvement. The role will translate process development knowledge into executable transfer packages, batch record inputs, risk assessments, comparability strategies, technical troubleshooting plans, and campaign-support documentation in partnership with Quality, Regulatory CMC, Analytical Development, Supply Chain, Program Management, and external manufacturing teams. The successful applicant will also contribute to the development of novel process technologies, IPs, and cost of goods reduction assessment. Prior knowledge or experience of nucleic acids is required.

Experience

BS/MS/PhD in Organic Chemistry, Biochemistry, Chemical Engineering, or a related scientific discipline
6+ years of relevant experience with BS, 5+ years with MS, or 4+ years with PhD in oligonucleotide process development, GMP manufacturing, technology transfer, CMC, or external manufacturing oversight
Direct experience working with CDMOs, CROs, manufacturing partners, or cross-functional CMC project teams is strongly preferred
Strong technical understanding of oligonucleotide synthesis, purification, UF/DF, annealing where applicable, lyophilization, impurity control, and related analytical characterization
Hands-on experience with ÄKTA, Waters, Sartorius, and equivalent oligonucleotide synthesis, purification, characterization, and analytical instrumentation is preferred
Knowledge of cGMP expectations, data integrity principles, quality risk management, process validation lifecycle concepts, FMEA, and applicable regulatory standards, including ICH, FDA, EMA, and other global health authority expectations

Responsibilities

Process optimization in oligonucleotide synthesis, deprotection, purification, conjugation, ligation, annealing, lyophilization and related processing activities to support continuous improvement, lifecycle reduction and related CMC development activities
Lead or support external transfer of oligonucleotide drug substance processes to CDMOs from development readiness through GMP execution, including synthesis, cleavage/deprotection, purification, UF/DF, annealing, concentration and lyophilization
Serve as a primary technical interface with external manufacturing partners for transfer package review, facility fit, equipment configuration, batch record development, campaign preparation, process monitoring, technical troubleshooting, and post-campaign evaluation
Support the preparation and maintenance of transfer documentation, including process descriptions, transfer plans, equipment fit assessments, process parameter tables, control strategies, risk assessments, comparability protocols, batch record inputs, campaign summaries, and technical reports