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.DescriptionWave 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.ExperienceBS/MS/PhD in Organic Chemistry, Biochemistry, Chemical Engineering, or a related scientific discipline6+ 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 oversightDirect experience working with CDMOs, CROs, manufacturing partners, or cross-functional CMC project teams is strongly preferredStrong technical understanding of oligonucleotide synthesis, purification, UF/DF, annealing where applicable, lyophilization, impurity control, and related analytical characterizationHands-on experience with ÄKTA, Waters, Sartorius, and equivalent oligonucleotide synthesis, purification, characterization, and analytical instrumentation is preferredKnowledge 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 expectationsResponsibilitiesProcess optimization in oligonucleotide synthesis, deprotection, purification, conjugation, ligation, annealing, lyophilization and related processing activities to support continuous improvement, lifecycle reduction and related CMC development activitiesLead 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 lyophilizationServe 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 evaluationSupport 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 reportsSupport technical knowledge-transfer meetings, gap assessments, readiness reviews, process walkthroughs, pre-campaign risk reviews, discrepancy triage, and action tracking with external partners and internal stakeholdersLead 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 escalatedProvide 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 clarificationsPartner 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 supplySupport process characterization, validation readiness, comparability assessments, PPQ strategy, and lifecycle management for externally manufactured oligonucleotide drug substanceReview and interpret in-process, release, stability, and characterization data from internal and external campaigns for comparability and batch consistencyContribute 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 rationaleIdentify 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 stakeholdersKey SkillsStrong technical judgment and ability to troubleshoot oligonucleotide manufacturing issues using process history, batch record review, analytical data, equipment performance, material attributes, and scientific first principlesDexterity, imagination, creativity and ability to come up with innovative solutions to unique process challenges in the laboratoryDemonstrated ability to manage multiple external technical workstreams, including transfer deliverables, open technical questions, readiness risks, deviation follow-up, data review, and post-campaign action itemsComfortable operating in a matrixed environment with limited supervision, escalating technical and compliance risks appropriately, and driving data-based resolution of process or manufacturing issuesWillingness 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 neededPay Range Disclosure Statement$130,000—$199,000 USDThe 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.Wave Life Sciences expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Wave Life Sciences’ employees to perform their job duties may result in discipline up to and including discharge.We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Wave Life Sciences, USA.Data Privacy and Your InformationBy submitting your information in applying for a position at Wave (or lawfully on behalf of a candidate as an approved recruiter), you represent that the information you submit (including your name, phone number, email address, address, and resume/CV/work history) is true and accurate, you have the right to share it, and that no part of the Information violates or infringes the rights of any third parties. If you submit information lawfully on behalf of another applicant as an approved recruiter, you confirm that you have the right to so submit. You grant Wave permission to use your information to contact you in connection with this or another position, for interviews, scheduling purposes, travel arrangements, or follow up after a decision on the role has been made.Wave Life Sciences is committed to respecting your privacy. We do not sell or rent personal information to third parties for marketing purposes. Any Personal Information you share with us will be used for business purposes, such as communication with you, and handled in accordance with Wave’s Privacy Policy, Notice, Statements, and Additional Information. Wave collects, evaluates and retains candidate data for the legitimate interest of selecting a candidate for employment or contract purposes. Such data will be kept for no longer than necessary to carry out those purposes, unless you consent for your information to be retained up to an additional three (3) years for consideration for future opportunities at Wave. Any requests related to your Personal Information may be electronically submitted to Wave’s Data Protection Officer at .If you choose to share your demographic background (such as race, gender or sex, national origin, age, disability or veterinary status) by completing the optional survey, your responses will be combined with the answers from other applicants in an aggregated and anonymized form which may be used for equal employment opportunity reporting, diversity and inclusion analysis, and to help us evaluate the effectiveness of our recruiting practices. The information you share will not be used for hiring decisions or provided to hiring managers or interviewers.