Principal Scientist, Project Toxicologist

This is a fully remote position, open to applicants in United States.

📋 Description

• Deliver scientific and strategic leadership for the development, validation, transfer, and implementation of immunogenicity assays across both nonclinical and clinical programs.

• Act as a senior subject-matter expert in ADA, NAb, drug-tolerant, cell-based, and predictive immunogenicity assay methodologies.

• Utilize global regulatory guidelines, GLP/GCP standards, and statistical principles for assay validation to inform program decisions.

• Oversee complex data interpretation, troubleshooting, and risk assessment pertaining to the immunogenicity bioanalytical strategy.

• Ensure scientific quality, compliance, and timely delivery by providing oversight for assay transfers to CROs and leading troubleshooting efforts.

• Collaborate with drug development teams, research groups, compliance, outsourcing teams, and senior stakeholders within a matrixed environment.

• Contribute to regulatory submission documents and address inquiries from regulatory reviews.

• Mentor scientists and supervise or support laboratory personnel.

• Aid in building functional capabilities, fostering innovation, and developing best practices.

⛳️ Requirements

• Doctorate in Biochemistry, Molecular Biology, Cell Biology, Immunology, or a related discipline [and pertinent post-doctorate experience where applicable] and 3 years of scientific/technical industry experience, OR a Master’s degree with 6 years of scientific/technical industry experience, OR a Bachelor’s degree with 8 years of scientific/technical industry experience.

• Proven expertise in the development, validation, and oversight of immunogenicity assays for detecting anti-drug binding and neutralizing antibodies in accordance with current global regulatory standards.

• Familiarity with Good Laboratory Practices (GLPs) and an understanding of Good Clinical Practices (GCP) guidelines.

• Experience in transferring immunogenicity assays to bioanalytical CROs.

• Knowledge of statistical methodologies relevant to immunogenicity assays.

• Understanding of drug-tolerant assay formats for ADA and NAb detection.

• Proficiency in cell-based assay formats for NAb detection.

• Expertise in predictive immunogenicity techniques employing cell-based or ligand-binding approaches.

• Experience in a supervisory and mentoring capacity within a laboratory environment.

• Capability to analyze and interpret data related to assay development, validation, and troubleshooting.

• Competence in multitasking and managing various projects simultaneously.

• Excellent verbal and written communication abilities.

• Previous experience in a matrixed organizational setting.

• Project management skills essential for meeting critical deadlines.

• Ability to work independently while collaborating effectively with cross-functional teams.

🏝️ Benefits

• A comprehensive employee benefits package that includes a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models where feasible.

• Opportunities for career development.

• Support for work/life balance.