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 candidate should have hands-on experience and knowledge of ligand-binding assays and cell-based Nab assays development and validation. They will collaborate cross-functionally, interface with CROs, and have experience with bioanalytical regulatory guidance and industry practices.

• 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 and cell-based Nab assays development and validation.
• Plan and execute activities in 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.
• Interface with GLP/GCLP CROs as the bioanalytical SME for 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.
• 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
• 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
• Ability to maintain bioanalytical assay performance and manage critical bioanalytical reagent inventory
• Collaboration skills to work cross-functionally with CMC and Research teams, developing methods for internal analytical characterization or testing
• Experience in interfacing with GLP/GCLP CROs as the bioanalytical SME for both clinical and non-clinical programs
• Familiarity with reviewing 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.

• Competitive salary range of $113,000 - $138,000
• Opportunity to join an exciting, fast-paced company
• Market cap of over $500M and financial runway well into 2025
• Chance to contribute to the development of therapeutics targeting immunomodulatory receptors
• Focus on allergic, inflammatory, and proliferative diseases
• Potential for broad inhibition of inflammatory cells
• Opportunity to work on advanced antibodies lirentelimab (AK002) and AK006
• Clinical development focused on atopic dermatitis and chronic spontaneous urticaria
• Plans to begin human clinical trials with AK006 in the first half of 2023
• Responsibility for contributing to the development, qualification, and validation of Ligand-Binding Assays (LBA)
• Opportunity to assist in analytical method development
• Hands-on experience and knowledge of ligand-binding assays and cell-based Nab assays
• Ability to plan and execute activities independently
• Opportunity to interpret data, write reports, and present results
• Maintenance of bioanalytical assay performance and management of critical bioanalytical reagent inventory
• Collaboration with cross-functional teams to support CMC and Research
• Interface with GLP/GCLP CROs for clinical and non-clinical programs
• Exposure to current bioanalytical regulatory guidance and industry practices
• Opportunity to draft relevant sections for regulatory submissions
• Minimum qualifications of a degree in bioanalysis, pharmacology, immunology, or a related scientific field
• Hands-on experience conducting and trouble-shooting ligand-binding assays
• Working knowledge of GLP/GMP regulations and ICH guidelines
• Familiarity with other common analytical characterization methods for biological drug substances
• Knowledge of IDBS, MSD platform, and SoftMax™ Pro
• Self-motivated and detail-oriented work environment
• Opportunity to adhere to company quality system standards, policies, SOPs, and guidelines
• Allakos Values: Selflessness, Drive, Clarity, Thoughtfulness, Fun, and Leadership
• Equal opportunity employer