Mirador is a next-generation precision medicine company focused on immunology and inflammation. The company's Mirador360 TM precision development engine leverages the latest advances in human genetics and cutting-edge data science to rapidly advance new precision medicines for patients living with chronic immune-mediated inflammatory and fibrotic diseases. Launched in 2024, Mirador has raised over $400 million from leading life sciences investors and is based in San Diego, CA.
Summary
We are seeking a talented Associate Director, Bioanalytical to join our R&D team. This role will be responsible for overseeing the development, validation, and implementation of PK, immunogenicity, and cell-based assays at our state-of-the-art lab in San Diego, CA. The successful candidate must have industry experience in biological assay development and be proficient, in method development/qualification/validation and all bioanalytical aspects of biologics drugs.
Responsibilities
- This lab-based position is responsible for overseeing the development, validation, and implementation of PK, immunogenicity, and cell-based assays including but not limited to detection of Anti-Drug Antibodies, use of Idiotypic antibodies for PK/ADA assays, ligand-binding and neutralization assays in both the regulated and non-regulated environment to support biologics drug candidates (monoclonal and bispecific antibodies) in pre-clinical and clinical development.
- Performing lab work and managing CROs and CMOs to develop, validate, and execute bioanalytical and cell-based potency assays, and for interpreting and reporting bioanalytical results to support drug discovery and clinical development activities.
- Collaborate internally with discovery, translational, protein engineering, CMC, clinical development, and also working closely with multiple external contract organizations including contract laboratories and CMOs in the areas of method transfer, qualification/validation and implementation of QC methods.
Experience and Qualifications
- Masters's degree in a biology/biochemistry discipline required, PhD strongly preferred.
- 8 or more years biotechnology/pharmaceutical industry experience in bioanalytical assay development and deployment is required.
- Knowledge and hands-on experience with method development, qualification, and validation of cell-based bioassay for potency measurement to support GMP manufacturing, product characterization, lot release, and stability testing are required.
- Experience working closely with and managing CROs is required.
- Must have in-depth knowledge and hands-on experience in plate-based and cell-based assay development, execution and troubleshooting, as well as expert knowledge of methods and immunoassay technologies, such as ELISA (direct and indirect sandwich formats), Luminescence, Colorimetric, Electrochemiluminescence (MSD), etc. to support preclinical and clinical studies. A thorough knowledge of GLP, GCP, Bioanalytical and Immunogenicity Guidance (FDA/EMA) is desirable.
Skills and Abilities
- Leadership capabilities for cross functional teams with exceptional organizational and communication skills.
- Ability to work on several projects and assignments at the same time, with appropriate prioritization.
- Thorough understanding of global health authority expectations in bioanalytical space for biologics drug development and registration in immunology/inflammation therapeutic area.
- A commitment to collaborative leadership, management, teamwork, delegation and foster a professional culture based on trust and mutual respect in a fast-paced environment.
- Occasional travel to CRO site may be required (10-15%).
The expected base pay range for this position is $150,000 - $190,000 plus bonus, equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. This range may be modified in the future.
All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, veteran status or other protected class.
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