Alnylam Pharmaceuticals · 12 hours ago
Principal Scientist, Bioanalytical Sciences
Cambridge, MA
Full-time
Onsite
Senior Level, Lead/Staff
6+ years expAlnylam Pharmaceuticals is seeking a highly motivated Principal Scientist to join their Bioanalytical Sciences group to help advance novel RNAi therapeutic programs. The role involves managing outsourced efforts for bioanalytical sample analysis and collaborating with project teams to ensure successful method implementation and regulatory compliance.
BiotechnologyHealth CareMedicalPharmaceuticalTherapeutics
Responsibilities
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)
Qualification
Required
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
Company
Alnylam Pharmaceuticals
Alnylam Pharmaceuticals is a biopharmaceutical company focused on the discovery, development and commercialization.
1001-5000 employees
H1B Sponsorship
Alnylam Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (18)
2021 (19)
2020 (7)
Funding
Current Stage
Public CompanyTotal Funding
$4.55BKey Investors
Blackstone Life SciencesBlackstone CreditRegeneron
2025-09-09Post Ipo Debt· $661.25M
2022-09-12Post Ipo Debt· $900M
2022-03-04IPO
Leadership Team
Yvonne Greenstreet
Chief Executive Officer
Jeff Poulton
Chief Financial Officer
Recent News
Clinical Trials Arena
2026-01-16
Longevity.Technology
2026-01-14
2026-01-13
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