Alnylam Pharmaceuticals · 1 month ago
Senior Scientist, Bioanalytical - Immunogenicity
Cambridge, MA
Full-time
Onsite
Mid, Senior Level
$123K/yr - $184K/yr
3+ years expAlnylam Pharmaceuticals is seeking a highly motivated Senior Scientist in Bioanalytical Sciences, specializing in immunogenicity assessments. The role involves designing and conducting assays to evaluate immune responses, and developing bioanalytical methods to support drug development programs.
BiotechnologyHealth CareMedicalPharmaceuticalTherapeutics
Responsibilities
Apply background in molecular and cellular immunology to investigate the fundamental biology governing immunogenicity, develop immunogenicity risk assessments for novel therapeutics, and carry out immunogenicity testing to evaluate total anti-drug antibodies (ADA), neutralizing antibodies (NAb), and innate or cellular responses as needed
Independently develop and qualify novel ligand binding assays (ELISA and MSD) to support immunogenicity assessments to aid in the interpretation of pharmacokinetics (PK), pharmacodynamics (PD), or safety data in vivo. Transfer critical reagents or methods to Contract Research Organizations (CROs) as needed. Experience in performing cell-based immunoassays or flow cytometry-based assays for in vitro immunogenicity assessment will be a plus
Conduct non-GLP sample analysis to support all Alnylam’s RNAi therapeutic development from early to late stages
Serve as one of the point persons for flow cytometry-based assays, ligand binding assays, and cell-based assays, applying an in-depth understanding of the application of these platform technologies to support PK, PD, or immunogenicity assessments
Assist associate scientists in method optimization and troubleshooting assays
Aid in critically reviewing and troubleshooting internal and external ADA and NAb assays
Help implement and maintain appropriate procedures and controls to ensure consistent assay performance and reproducible data
Maintain laboratory notebooks, perform data analysis and QC, and communicate results to cross-functional teams
Collaborate with cross-functional teams within Research and Development to align on projects and timelines, and aid in interpretation of data
Research and implement new immunogenicity technologies to improve assay performance or address specific questions
Investigate areas for automation to increase quality or efficiency
Qualification
Required
Ph.D. in immunology with training in biochemistry, chemistry, molecular/cell biology, or related field with 3+ years of relevant industry experience or exceptional non-Ph.D. with 8+ years of industry experience
Possesses in-depth knowledge, hands on experience, and technical expertise on ADA and Nab immunogenicity ligand binding assays (ELISA and MSD), cell-based assays, or flow cytometry-based assays
Perform fit-for-purpose immunogenicity Ligand Binding Assay (LBA) method development and high-quality bioanalytical sample analysis as per FDA/ICH/EMA immunogenicity guidelines
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
Detail-oriented with exceptional organizational skills, the ability to handle multiple projects, and thrive in a fast-paced, team-oriented environment
Has strong interpersonal skills to enable collaboration with cross-functional teams
Possesses excellent verbal and written communication skills
Preferred
Knowledge of regulatory expectations for bioanalytical method qualification and validation or previous experience working in a bioanalytical GLP or non-GLP environment is preferred
Track record in preparing conference presentations, publications in peer reviewed journals, or industry and regulatory white papers
Knowledge of PCR and LC-MS methods are a plus
Experience in performing cell-based immunoassays or flow cytometry-based assays for in vitro immunogenicity assessment will be a plus
Benefits
Comprehensive benefits including medical, dental, and vision coverage
Life and disability insurance
Lifestyle reimbursement program
Flexible spending and health savings accounts
401(k) with a generous company match
Paid time off
Wellness days
Holidays
Two company-wide recharge breaks
Generous family resources and leave
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
Longevity.Technology
2026-01-14
2026-01-13
Company data provided by crunchbase