Sr. Scientist II, Immunoassay

Glaukos is looking for a motivated Principal Immunology Scientist to join the Pharmacokinetics, Drug Disposition, and Clinical Pharmacology team. This team develops and executes the nonclinical and clinical ADME strategy for our novel pharmaceutical products including developing and performing ligand binding assays (LBAs) to assess local biodistribution, systemic exposure, and quantitation of novel biologics in biological fluids and tissues. Additionally, this team is responsible for developing and executing the immunogenicity strategy for such projects,

A successful candidate will lead and manage external activities at CROs to provide timely bioanalytical and immunological support for Research and Development project teams. This candidate will demonstrate excellent collaboration and communication skills while serving as a subject matter expert advising colleagues from the Applied Research and Translational Sciences group (and other relevant departments) in how LBA and immunogenicity techniques may address key project questions. The ideal candidate would be versatile, self-motivated, timeline and process oriented, demonstrate independent method development skills and the ability to troubleshoot.

What You'll Do:

• Exercise independent judgement in the development, optimization, qualification, and validation of quantitative LBA methods and immunogenicity (anti-drug binding and neutralizing antibodies) assays for use in a variety of biological fluids and tissues, ensuring bioanalytical deliverables are met
• Collaborate with representatives from the drug development team to ensure suitability of the assay format for the therapeutic program.
• Oversee external CROs conducting method development, qualification, validation and sample analysis to enable PK/PD, GLP Tox, and clinical studies
• Write formal study reports and bioanalytical sections of regulatory documents (briefing books, INDs, NDAs) for submission to regulatory agencies.
• Discover and identify processes, novel science and state-of-the-art technologies and methodologies (both within and outside field of expertise) that enhance the department's ability to answer key research and development questions.
• Integrate input from different functional areas into effective solutions through close collaboration with colleagues in the non-clinical development organization and other relevant departments.
• Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines.
• Maintain an understanding and expertise in relevant industry regulations and compliance standard.

How You'll Get There:

• PhD and 7+ years of experience.
• Hands-on experience developing, qualifying, and validating quantitative LBA-based bioanalytical assays to support a variety of modalities (e.g. peptides and biologics) in biological fluids and tissues.
• Demonstrated expertise in the development, validation, and oversight of immunogenicity assays for detection of anti-drug. binding and neutralizing antibodies according to current global regulatory guidelines.
• Knowledge of statistical approaches applied to immunogenicity assays, drug-tolerant assay formats for ADA and NAb detection, and cell-based assay formats for NAb detection.
• Understanding of GLP requirements, current industry trends, and regulatory expectations associated with bioanalytical science. Knowledge of bioanalysis-associated FDA and ICH guidance.
• Experience in collaborating with, transferring, and monitoring CRO method development, validation, and sample analysis (both non-GLP and GLP) activities to ensure timely delivery of data to project team.
• Strong verbal and written communication skills.
• Strong organizational skills and keen attention to detail; ability to handle multiple projects in a fast-paced environment.
• Proven ability to work independently and to collaborate cross-functionally to accomplish goals in a timely manner.
• Basic understanding of pharmacokinetics and drug metabolism is helpful.