Scientist II/Sr. Scientist I, Process Technology Services, CMC

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
• Support technical knowledge-transfer meetings, gap assessments, readiness reviews, process walkthroughs, pre-campaign risk reviews, discrepancy triage, and action tracking with external partners and internal stakeholders
• Lead comparability and stage-gate readiness assessments after proof-of-concept or engineering runs and before GMP execution, ensuring technical risks, facility-fit gaps, process changes, and readiness criteria are documented and appropriately resolved or escalated
• Provide person-in-plant (PIP) or remote technical support during external manufacturing campaigns, including real-time review of process trends, atypical observations, in-process results, deviations, yield losses, impurity excursions, equipment issues, and batch record clarifications
• Partner with Quality, Regulatory CMC, Analytical Development, Supply Chain, Program Management, and External Manufacturing Operations to ensure phase-appropriate control strategy alignment, compliant execution, and timely delivery of clinical or commercial supply
• Support process characterization, validation readiness, comparability assessments, PPQ strategy, and lifecycle management for externally manufactured oligonucleotide drug substance
• Review and interpret in-process, release, stability, and characterization data from internal and external campaigns for comparability and batch consistency
• Contribute to technical investigations, deviation impact assessments, root cause analysis, change controls, process improvement plans, and health authority-supporting technical responses with scientifically sound, data-driven rationale
• Identify process, analytical, equipment, documentation, or control-strategy gaps during transfer and campaign execution; propose risk-based mitigation plans; and track actions to close with internal and external stakeholders

Key Skills

• Strong technical judgment and ability to troubleshoot oligonucleotide manufacturing issues using process history, batch record review, analytical data, equipment performance, material attributes, and scientific first principles
• Dexterity, imagination, creativity and ability to come up with innovative solutions to unique process challenges in the laboratory
• Demonstrated ability to manage multiple external technical workstreams, including transfer deliverables, open technical questions, readiness risks, deviation follow-up, data review, and post-campaign action items
• Comfortable operating in a matrixed environment with limited supervision, escalating technical and compliance risks appropriately, and driving data-based resolution of process or manufacturing issues
• Willingness and ability to travel to external manufacturing sites to support process transfer, equipment fit reviews, engineering runs, GMP campaigns, deviation investigations, PPQ preparation, and technical issue resolution as needed

Pay Range Disclosure Statement

$130,000—$199,000 USD

The range provided is based on what we believe is a reasonable estimate for the annual base salary pay range for this position at the time of posting. Actual annual base salary will vary based on several factors including, but not limited to, relevant skills, experience, qualifications, position criticality, and internal equity.  This position is eligible for a discretionary annual bonus and discretionary stock-based long-term incentives.  In addition to compensation, Wave offers a comprehensive and competitive range of benefits designed to support our employees’ and their families physical and financial health and overall well-being. These include, but are not limited to, company-sponsored medical, dental, vision, life, long and short-term disability insurances, generous paid time off (including a week-long company shutdown in the Summer and the Winter), 401K participation with matching contributions, and Employee Stock Purchase Program. Wave Life Sciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Wave Life Sciences complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

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