Principal Scientist, Bioanalytical Sciences

Provide scientific support for CRO efforts in the design, development, and implementation of a variety of analytical methods in a regulated (GLP, GCLP) environment. Serve as a subject matter expert in the application of bioanalytical techniques (ELISA, MSD, PCR, LC-MS, cell-based assays) to support PK, PD, biomarker, or immunogenicity objectives in nonclinical or clinical studies. Leverage depth of knowledge and hands-on experience with bioanalytical techniques to advise on assay design, method validation design, and interpretation of method performance data. Collaborate with Alnylam bioanalytical scientists to ensure successful method transfer and continuity in PK or PD biomarker testing from discovery through development. Participate in program team meetings, serving as a collaborative and reliable bioanalytical representative and team member to meet study timelines and drive programs forward. Participate in regular vendor meetings, provide critical reagents, review study plans, data transfer agreements, data and reports. Ensure delivery of quality bioanalytical and biomarker data and reports according to timelines. Apply creative problem-solving skills to address any issues that arise during assay development or sample analysis. Review bioanalytical contracts to ensure the scope of work accurately reflects project goals. Participate in writing and reviewing regulatory documents for initiation of clinical studies (such as IND and CTA) and drug approvals (such as NDA and MAA). PhD in biochemistry, chemistry, molecular/cell biology, or related field with 6+ years of relevant industry experience, or non-PhD with 10+ years of experience. Hands-on experience with the use of bioanalytical techniques such as ELISA, MSD, PCR, LC-MS, or cell-based methods to support PK, PD, or immunogenicity evaluations. Has previous experience in conducting or managing regulated (GLP, GCLP, CLIA) bioanalysis studies. Has experience in overseeing CRO bioanalysis work and/or direct experience as CRO scientist/principal investigator with sponsor interactions. Experience with writing or reviewing bioanalytical reports and contributing to regulatory submissions. Demonstrates a solid understanding of disease biology and the drug development process to enable design and implementation of assays that are fit for intended use. Strong relationship-building skills in working in a matrixed environment with both internal and external stakeholders. Possesses the ability to think creatively and strategically with strong problem-solving skills. Experienced with the drug approval process and the bioanalytical clinical development of nucleic acid (siRNA, ASO, mRNA, gene therapy), biologic, or small molecule drugs. Organized and detail-oriented with the ability to multi-task and handle multiple projects. Has excellent interpersonal and communication skills to enable effective collaboration with cross-functional teams.