Senior Scientist, Bioanalytical - Immunogenicity

Alnylam Pharmaceuticals • Cambridge, MA

232d

About The Position

The Bioanalytical Sciences group at Alnylam is seeking a highly motivated Senior Scientist, specializing in designing and conducting immunogenicity assessments including assays to evaluate the presence of anti-drug antibodies (ADA), neutralizing antibodies (NAb), and innate or cellular responses as needed. The Senior Scientist will utilize their background in molecular and cellular immunology to carry out immunogenicity risk assessments for novel drugs, and design assays that may be used to evaluate innate or adaptive immune responses (humoral or cell-mediated), and their potential impact on pharmacokinetics, pharmacodynamics, or safety and efficacy. This individual will be responsible for designing, developing, and implementing bioanalytical methods across various technologies, such as ELISA, MSD, Luminex, Quanterix, Flow Cytometry, and cell-based assays to evaluate the immunogenicity of novel drugs in support of early discovery through late-stage drug development programs. This is a bench scientist role that will support non-GLP preclinical studies, with method transfer as needed to our contract research organization (CRO) partners for GLP- or GCLP-regulated bioanalytical studies in support of later drug development efforts. This is an exciting opportunity to join a vibrant team and interact with highly motivated scientists across a broad array of disciplinary expertise areas.

Requirements

• 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. Knowledge of PCR and LC-MS methods is a plus.
• Perform fit-for-purpose immunogenicity Ligand Binding Assay (LBA) method development and high-quality bioanalytical sample analysis as per FDA/ICH/EMA immunogenicity guidelines.
• Knowledge of regulatory expectations for bioanalytical method qualification and validation or previous experience working in a bioanalytical GLP or non-GLP environment is preferred.
• 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.
• Track record in preparing conference presentations, publications in peer reviewed journals, or industry and regulatory white papers.
• 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.

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), cell-based immunoassays, or flow cytometry-based assays to support immunogenicity assessments to aid in the interpretation of pharmacokinetics and in vitro and in vivo safety assessments.
• 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 pharmacokinetics (PK), pharmacodynamics (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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree