Scientist/Senior Scientist, Bioanalytical (PK/ADA)
Allakos Inc. is a dynamic clinical-stage biopharmaceutical company developing first-in-class antibody-based therapeutics to treat allergic and inflammatory diseases.
The company is seeking to recruit a highly motivated Scientist/Senior Scientist with expertise in bioanalytical method development, validation and in-study sample testing to be a key member of the Analytical Development and Quality Control (ADQC) team. The scope of the position and requirements are described below.
The successful candidate will be primarily responsible for maintaining and improving pharmacokinetic (PK), anti-drug antibody (ADA), and neutralizing antibody (nAb) assays for late-stage antibody product development and working with GLP CROs for method validation and non-clinical/clinical sample testing.
The incumbent is expected to ensure the bioanalytical program meets the regulatory requirements and industry standard for a successful biologics license application (BLA). This position will report to the Director, ADQC.
- Interface with GLP CROs as the key SME in bioanalysis for both the clinical and non-clinical programs to support late-stage product development.
- Maintain, optimize or develop PK, ADA, nAb assays (cell-based or plate-based) in multiple sample matrix (e.g., mouse, minipig, human) and manage method validation at GLP CROs.
- Identify potential gaps in the method procedure and validation to ensure the methods and validation studies are designed and executed in compliance with current regulatory guidance and industrial practices.
- Review relevant assay development data, study plan, validation protocols and reports from CROs.
- Drive the nAb assay development and transfer to GLP CRO.
- Monitor the regulated PK and ADA sample testing, assay performance and troubleshoot assay related issues with GLP CRO to ensure the sample testing is on track.
- Manage critical bioanalytical reagent inventory, outsource the generation of anti-idiotypic antibodies for ADA assays.
- Participate in immunogenicity risk assessments and develop tiered patient sample testing
- Work with project manager and clinical operation/non-clinical team to plan the PK and immunogenicity assay timelines and budget.
- Perform non-GLP PK and immunogenicity sample testing in house to support product development as needed.
- Be cross-trained on CMC analytical methods for in-house analytical development or testing support (e.g., bioassay).
- Write or review Allakos technical reports, memos, and relevant sections for IND/BLA or other regulatory submissions.
- Critical scientific/technical data analysis and presentation of data in project team meetings.
- Degree (BS, MS, PhD) in bioanalysis, pharmacology, immunology, or a related scientific field. Requirement for Sr. Scientist is minimum of 5 years of relevant industry experience for PhD, 12 years for MS and 14 years for BS level candidates. For Scientist, the minimum requirement is 0 years for PhD, 6 years for MS and 8 years for BS.
- Extensive experience in development, transfer, and validation of regulated PK, ADA and nAb assays with GLP CROs.
- Previous hands-on experience in using Meso Scale Discovery (MSD) and GyroLab platform and software analysis is preferred.
- Thorough understanding of relevant FDA, ICH and USP chapters, industry white papers, and GLP requirements for ligand-binding assays (LBA) for Phase III clinical trial and BLA.
- Understanding of ADA and nAb assay data analysis, outlier identification, and cutpoint determination methodologies.
- Prior experience working with antibody molecules is desirable.
- Strong interpersonal skills and excellent oral and written communication skill is a must. Demonstrated capability to work with team members to troubleshoot and identify solutions.
- Flexible to work in the lab and support the CMC activities as needed.
- Prior experience conducting technical audits of CROs is a plus.
- Prior experience in bioassay is a plus.
- Ability to work effectively in a goal-oriented, fast-paced, matrixed team environment.
The salary is competitive and commensurate with experience and qualifications.
Interested applicants please send resume to CMCcareers@allakos.com
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.