Senior Scientist - CMC

• You will be responsible for supporting the synthesis, purification, and characterization of oligonucleotides and their conjugates, and optimizing methodologies to support the development of siRNA medicines. The ideal candidate will have experience in organic and analytical chemistry and both upstream and downstream oligonucleotide manufacturing processes. A key focus of this role will be developing scalable processes suitable for technology transfer to CDMOs. You will be expected to –
• Perform solid-phase synthesis, purification, and characterization of oligonucleotides
• Develop and optimize scalable upstream (synthesis) and downstream (purification, formulation) manufacturing processes
• Support process development activities to enable successful technology transfer to CDMOs
• Analyze, interpret, and clearly communicate synthetic and analytical data
• Present findings to senior staff and cross-functional teams
• Troubleshoot and refine synthesis and purification protocols
• Manage multiple projects simultaneously in a fast paced environment
• Support GLP related activities and IND-enabling process development efforts

• This position requires a BS in Chemistry with at least 12 years of relevant industry experience, or an MS in Organic Chemistry, Biochemistry, or Chemical Engineering with at least 7 years of relevant experience, or a PhD with at least 3 years of relevant experience.
• Industry experience in solid-phase oligonucleotide synthesis is preferred, as well as familiarity with both upstream and downstream oligonucleotide manufacturing processes
• Minimum 1 year of experience working in a cGMP environment with demonstrated understanding of cGMP principles
• Hands-on proficiency with analytical instrumentation such as NMR, LC-MS, and RP-HPLC
• Demonstrated ability in analytical and purification method development using RPIP-HPLC, AEX-HPLC, UV, MALDI, and HRMS
• Background in process development and technology transfer to CDMOs, including development of scalable purification and formulation methodologies
• Working knowledge of tangential flow filtration (TFF) method development
• Experience supporting GLP studies and familiarity with regulatory expectations for IND-enabling work
• Experience with lyophilization and aseptic fill/finish operations
• Applicants must have authorization to work in the U.S.

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