BioSpace
Scientist, Bioanalytical - San Diego, CA
BioSpace, San Diego, California, United States, 92189
Scientist, Bioanalytical - San Diego, CA
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.
We are seeking a motivated, versatile, detail‑oriented Scientist to join the Bioanalytical Team. The focus will be 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 skilled in method development/qualification/validation and all bioanalytical aspects of biologics drugs.
Responsibilities
This lab‑based position will conceptualize and perform PK, immunogenicity, and cell‑based assays including but not limited to support detection of Anti‑Drug Antibodies (ADAs), 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.
Conduct lab work and collaborate with CROs and CMOs to develop, validate, and execute bioanalytical and cell‑based potency assays, as well as interpret and report results to support drug discovery and clinical development activities.
Collaborate internally with immunology, protein engineering, CMC, clinical development teams, and work 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
Bachelor’s degree in biology/biochemistry or related discipline
8 or more years of biotechnology/pharmaceutical industry experience in bioanalytical assay development or Master’s degree with 6 or more years of relevant experience
Knowledge and hands‑on experience with method development, qualification, and validation of cell‑based bioassays for potency measurement to support GMP manufacturing, product characterization, lot release, and stability testing are required.
Experience collaborating with CROs.
Strong knowledge of immunoassay (plate‑based and cell‑based assay) development, execution and troubleshooting, as well as hands‑on experience in immunoassay technologies, such as ELISA (direct and indirect sandwich formats), Luminescence, Colorimetric, Electrochemiluminescence (MSD), etc. to support preclinical and clinical studies.
Familiarity with GLP, GCP, Bioanalytical and Immunogenicity Guidance (FDA/EMA) is desirable.
Skills and Abilities
Independent, self‑motivated life scientist with the ability to generate scientific questions and design experiments to address them.
Excellent problem‑solving, analytical and organizational skills.
Strong interpersonal and communication skills including presenting data to all levels of the organization.
Understanding of global health authority expectations in bioanalytical space for biologics drug development and registration in immunology/inflammation therapeutic area.
Demonstrates scientific rigor and curiosity to address scientific questions and design experiments to test a working hypothesis.
Ability to work in a fast‑paced and matrix environment to meet project deadlines.
Compensation The expected base pay range for this position is $110,000 – $135,000 plus bonus, equity, and comprehensive benefits.
Employment Details Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Research, Analyst, and Information Technology
Industries: Internet News
Community Working at Mirador Therapeutics | Great Place To Work®
Equal Opportunity 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.
Read our Job Applicant Privacy Policy
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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.
We are seeking a motivated, versatile, detail‑oriented Scientist to join the Bioanalytical Team. The focus will be 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 skilled in method development/qualification/validation and all bioanalytical aspects of biologics drugs.
Responsibilities
This lab‑based position will conceptualize and perform PK, immunogenicity, and cell‑based assays including but not limited to support detection of Anti‑Drug Antibodies (ADAs), 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.
Conduct lab work and collaborate with CROs and CMOs to develop, validate, and execute bioanalytical and cell‑based potency assays, as well as interpret and report results to support drug discovery and clinical development activities.
Collaborate internally with immunology, protein engineering, CMC, clinical development teams, and work 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
Bachelor’s degree in biology/biochemistry or related discipline
8 or more years of biotechnology/pharmaceutical industry experience in bioanalytical assay development or Master’s degree with 6 or more years of relevant experience
Knowledge and hands‑on experience with method development, qualification, and validation of cell‑based bioassays for potency measurement to support GMP manufacturing, product characterization, lot release, and stability testing are required.
Experience collaborating with CROs.
Strong knowledge of immunoassay (plate‑based and cell‑based assay) development, execution and troubleshooting, as well as hands‑on experience in immunoassay technologies, such as ELISA (direct and indirect sandwich formats), Luminescence, Colorimetric, Electrochemiluminescence (MSD), etc. to support preclinical and clinical studies.
Familiarity with GLP, GCP, Bioanalytical and Immunogenicity Guidance (FDA/EMA) is desirable.
Skills and Abilities
Independent, self‑motivated life scientist with the ability to generate scientific questions and design experiments to address them.
Excellent problem‑solving, analytical and organizational skills.
Strong interpersonal and communication skills including presenting data to all levels of the organization.
Understanding of global health authority expectations in bioanalytical space for biologics drug development and registration in immunology/inflammation therapeutic area.
Demonstrates scientific rigor and curiosity to address scientific questions and design experiments to test a working hypothesis.
Ability to work in a fast‑paced and matrix environment to meet project deadlines.
Compensation The expected base pay range for this position is $110,000 – $135,000 plus bonus, equity, and comprehensive benefits.
Employment Details Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Research, Analyst, and Information Technology
Industries: Internet News
Community Working at Mirador Therapeutics | Great Place To Work®
Equal Opportunity 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.
Read our Job Applicant Privacy Policy
#J-18808-Ljbffr