Senior Scientist, Bioanalytical - Immunogenicity

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.

The ideal candidate will have a strong background in molecular and cellular immunology to lead investigations into the fundamental biology governing immunogenicity and develop strategies for immunogenicity risk assessments of novel therapeutics, plus biochemistry or molecular and cellular biology training that may be applied to carry out these strategies through creative and thoughtful assay design. 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.

This position is onsite and will be primarily located in Cambridge, MA.

Key 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.

Qualifications

• 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.

About Alnylam:Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by "interfering" with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture:Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we've been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK - among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.