Scientist, Bioanalytical/Analytical

Scientist, Bioanalytical/Analytical

Allakos (Nasdaq: ALLK) is a clinical stage biotechnology company developing therapeutics which target immunomodulatory receptors present on immune effector cells involved in allergic, inflammatory and proliferative diseases. Activating these immunomodulatory receptors allows for the direct targeting of cells involved in disease pathogenesis and, in the setting of allergy and inflammation, has the potential to result in broad inhibition of inflammatory cells.

The Company’s most advanced antibodies are lirentelimab (AK002) and AK006. Lirentelimab selectively targets both mast cells and eosinophils, two types of white blood cells that are widely distributed in the body and play a central role in the inflammatory response. Inappropriately activated mast cells and eosinophils have been identified as key drivers in a number of severe diseases affecting the gastrointestinal tract, eyes, skin, lungs and other organs. Allakos’s lirentelimab clinical development is focused on atopic dermatitis and chronic spontaneous urticaria. Both indications are in phase 2 trials with data readouts expected in late Q4 2023 to Q1 2024. AK006 targets Siglec-6, an inhibitory receptor expressed selectively on mast cells. In pre-clinical research, AK006 appears to provide deeper mast cell inhibition than lirentelimab and, in addition to its inhibitory activity, reduce mast cell numbers.

Position Summary: 

The candidate will be 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. This role will also assist analytical method development to characterize drug functional attributes.

Position Responsibilities:

• Have 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.
• Plan and execute activities in area of bioanalytical/analytical method development independently.
• Perform development data interpretation, 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 to support products across different stages of development.
• 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.

Qualifications

• Degree (BS, MS, PhD) in bioanalysis, pharmacology, immunology, or a related scientific field. Requirement for Scientist is minimum of 2 years for PhD, 4 years of relevant industry experience for MS and 6 years for BS level candidates.
• Must have hands-on experience conducting and trouble-shooting ligand-binding assays. Experience with method development and robustness testing highly desirable.
• Working knowledge of and experience with GLP/GMP regulations and ICH guidelines is desirable.
• Familiarity with other common analytical characterization methods for biological drug substances is plus.
• Knowledge of IDBS, MSD platform, and SoftMax™ Pro is a plus.
• Individual must be self-motivated, detail oriented, and capable of working in a fast-paced environment on multiple tasks with minimum supervision.
• Able to maintain current training record and adhere to company quality system standards, policies, SOPs and guidelines.

Salary range: $113,000 - $138,000. This range is what Allakos reasonably expects to pay for this position and offers will be informed by experience, qualifications, and skills.

The Allakos Values are: Selflessness, Drive, Clarity, Thoughtfulness, Fun, and Leadership

Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.