Associate Director, Bioanalytical - San Diego, CA

Mirador Therapeutics, Inc. • San Diego, CA

1d • Onsite

About The Position

Mirador Therapeutics, Inc. is a clinical-stage precision medicine company focused on developing first-and/or best-in-class next-generation therapeutics for immunology and inflammation. The company’s Mirador360™ precision development engine leverages the latest advances in human genetics and data science to rapidly deliver new precision medicines for patients living with immune-mediated inflammatory and fibrotic diseases. Mirador has raised over $650 million from leading life sciences investors and is based in San Diego, CA. Mirador was named Best Places to Work by Biospace and is a Great Place to Work-Certified™ Company.

Requirements

• MASTER'S DEGREE (OR FOREIGN EQUIVALENT) IN BIOLOGY, BIOCHEMISTRY, CHEMISTRY OR CLOSELY RELATED FIELD PLUS 8 YEARS OF WORK EXPERIENCE IN THE BIOTECHNOLOGY/ PHARMACEUTICAL INDUSTRY OR IN A CLOSELY RELATED OCCUPATION.
• 8 years of experience with bioanalytical assay development and deployment
• 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
• Experience working closely with and managing CROs
• 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.
• Thorough understanding of global health authority expectations in bioanalytical space for biologics drug development and registration in immunology/inflammation therapeutic area.
• MUST POSSESS EXPERTISE/KNOWLEDGE SUFFICIENT TO ADEQUATELY PERFORM THE DUTIES OF THE JOB BEING OFFERED. EXPERTISE/KNOWLEDGE MAY BE GAINED THROUGH EMPLOYMENT EXPERIENCE OR EDUCATION. SUCH EXPERTISE/KNOWLEDGE CANNOT BE QUANTIFIED BY TIME.

Responsibilities

• Responsible for development, validation, and implementation of PK, immunogenicity, and cell-based assays at our state-of-the-art lab in San Diego, CA.
• 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.
• Perform 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager