Scientist, Bioanalytical/Analytical

The Scientist, Bioanalytical/Analytical position at Allakos is responsible for contributing to the development, qualification, assay transfer, and validation of Ligand-Binding Assays (LBA) for pharmacokinetic (PK), toxicokinetic (TK), and anti-drug antibodies (ADA) to support testing for non-GLP, GLP, and clinical studies. The role also involves assisting in analytical method development to characterize drug functional attributes. The ideal candidate should have hands-on experience and knowledge of ligand-binding assays and cell-based Nab assays development and validation applicable to support nonclinical GLP and clinical studies. This position offers the opportunity to join a fast-paced company with multiple studies expected to read out in 2023.

• Contribute to the development, qualification, assay transfer, and validation of Ligand-Binding Assays (LBA) for PK, TK, and ADA testing in non-GLP, GLP, and clinical studies.
• Assist in analytical method development to characterize drug functional attributes.
• Have hands-on experience and knowledge of ligand-binding assays (e.g., PK, ADA) and cell-based Nab assays development and validation for nonclinical GLP and clinical studies.
• Plan and execute activities in the area of bioanalytical/analytical method development independently.
• Interpret development data, write development reports, and present results in team meetings.
• Maintain bioanalytical assay performance and manage critical bioanalytical reagent inventory.
• Collaborate cross-functionally to support CMC and Research, developing methods for internal analytical characterization or testing as needed (e.g., bioassay).
• Interface with GLP/GCLP CROs as the bioanalytical SME for both clinical and non-clinical programs.
• Review relevant assay development data, study plans, protocols, and reports from CRO(s).
• Have experience/exposure to current bioanalytical regulatory guidance and industry practices, to draft relevant sections for IND/BLA or other regulatory submissions as needed.

• Hands-on experience and knowledge of ligand-binding assays (e.g., PK, ADA) and cell-based Nab assays development and validation applicable to support nonclinical GLP and clinical studies is required.
• Ability to plan and execute activities in the area of bioanalytical/analytical method development independently.
• Proficiency in development data interpretation, report writing, and presentation of results in team meetings.
• Experience in maintaining bioanalytical assay performance and managing critical bioanalytical reagent inventory.
• Collaboration skills to work cross-functionally with CMC and Research teams, developing methods for internal analytical characterization or testing as needed.
• Familiarity with interfacing with GLP/GCLP CROs as the bioanalytical SME for both clinical and non-clinical programs.
• Ability to review relevant assay development data, study plans, protocols, and reports from CRO(s).
• Exposure to current bioanalytical regulatory guidance and industry practices, with the ability to draft relevant sections for IND/BLA or other regulatory submissions as needed.
• A degree (BS) in a relevant field.

• Opportunity to join an exciting, fast-paced company
• Market cap of over $500M
• Financial runway well into 2025
• Competitive salary range of $113,000 - $138,000
• Hands-on experience and knowledge of ligand-binding assays
• Opportunity to contribute to the development, qualification, assay transfer, and validation of assays
• Ability to work independently in bioanalytical/analytical method development
• Collaboration with cross-functional teams
• Exposure to current bioanalytical regulatory guidance and industry practices
• Opportunity to draft relevant sections for regulatory submissions
• Self-motivated and detail-oriented work environment
• Equal opportunity employer