Postdoctoral Research Fellow (CMC Process Technology)

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 includes editing, splicing, RNA interference and antisense silencing, providing us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Our diversified pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency and Huntington’s disease, as well as a preclinical program in obesity. 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 seeks a highly motivated and talented postdoctoral research fellow to join its Oligonucleotide CMC Process Technology team in Lexington, Massachusetts. This individual will contribute to the development, scale-up, and transfer of manufacturing technologies for Wave’s RNA Therapeutics across clinical and commercial phases. This role will bridge process development and GMP manufacturing, ensuring successful tech transfer to internal and external manufacturing sites. 

Experience

• Recent or upcoming graduate with a PhD in Chemistry, Biochemistry, Chemical Engineering, or a related discipline
• Strong knowledge of organic chemistry, oligonucleotides synthesis, deprotection and purification techniques
• Experience with automated oligo or peptide solid phase synthesizers and purifiers
• Experience with analytical techniques e.g., UPLC, IEX, LC-MS and UV spectrometry
• Applicants with a background in Nucleic Acids will have an added advantage

Responsibilities

Will include some or all of the following:

• Support technology transfer activities of oligo drug substance (DS) processes from development to GMP manufacturing
• Support scale-up optimization, risk & gap analysis, and facility fit evaluation
• Author and review technology transfer documentation including process descriptions, risk assessments, comparability protocols, and batch records
• Participate in process scale-up, troubleshooting and root cause investigations during tech transfer campaigns
• Perform process evaluation experiments
• Conduct analysis of in-process and final samples by UPLC and LCMS
• Collaborate with Process Development, Quality, Regulatory, Supply Chain and Program Management to ensure tech transfer success
• Support technical oversight during manufacturing campaigns and on-the-floor activities including person-in-plant (PIP) responsibilities
• Analyze process data, summarize performance metrics and contribute to continuous improvement initiatives
• Capture, translate and present high-level details of complex process information in clear and concise summary presentations to assist in rapid decision making
• Keep abreast of emerging trends and technologies in oligonucleotides manufacturing

Key Skills & Attributes

• Strong analytical, problem-solving and root cause analysis skills
• Effective communication and documentation abilities
• Strong organizational, interpersonal skills, and ability to thrive in a cross-functional environment
• Ability to take on additional responsibilities including laboratory management, equipment maintenance and lab organization
• Knowledge of applicable regulatory and quality standards (ICH, FDA, EMA) is desired

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.