GondolaBio
Principal Scientist/Associate Director, Bioanalytical Sciences
GondolaBio, Palo Alto, California, United States, 94306
Principal Scientist/Associate Director, Bioanalytical Sciences
This role description has been refined for clarity and compliance. The following content reflects responsibilities, qualifications, and compensation information relevant to the position. Base pay range
$190,000.00/yr - $250,000.00/yr Company Background GondolaBio is a collection of biopharmaceutical companies focused on developing next-generation therapeutics for genetic diseases. Originally carved out of BridgeBio, GondolaBio secured $300M in private financing from external investors in 2024 and became an independent company within the BridgeBio ecosystem. GondolaBio aims to leverage cutting-edge biological research to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases. GalactaBio is a preclinical stage biotechnology company developing a novel potential best-in-class AAV gene therapy for classic galactosemia, a severe genetic metabolism disorder. Who You Are We are seeking an experienced
Principal Scientist/Associate Director in Bioanalytical Sciences
to lead bioanalytical strategy and execution for our
AAV-based gene therapy asset for the treatment of classic galactosemia . This individual will play a key leadership role in overseeing bioanalytical and biomarker method development, qualification, and validation through
effective CRO management
and cross-functional collaboration. The ideal candidate brings deep expertise in bioanalytical sciences for gene therapy, strong vendor management skills, and experience contributing to regulatory filings. Responsibilities
Lead the design and execution of bioanalytical strategies for AAV gene therapy programs, spanning preclinical through clinical development. Oversee and manage CROs/contract labs performing bioanalytical assays (qPCR/ddPCR, ELISA, ECL, LC-MS/MS, NGS, etc.) for biodistribution, pharmacokinetics, pharmacodynamics, immunogenicity, and biomarker assessments. Provide scientific and technical oversight of assay development, validation, and sample analysis at CROs to ensure regulatory compliance (GLP/GCP). Serve as the primary point of contact between internal teams and CRO partners to ensure quality, timelines, and deliverables. Partner with preclinical, clinical, and regulatory colleagues to integrate bioanalytical data into study design, data interpretation, and regulatory submissions (e.g., IND, CTA, BLA). Author/review bioanalytical sections of protocols, validation reports, study reports, and regulatory filings. Monitor emerging regulatory guidance in gene therapy bioanalytics and ensure alignment of internal and CRO practices. Travel: up to 20% of time Education, Experience & Skills Requirements
Ph.D. in Molecular Biology, Biochemistry, Pharmacology, or related discipline with
8+ years
of industry experience in bioanalytical sciences; or M.S. with
10+ years . Demonstrated expertise in nucleic acid and protein bioanalytical methods (qPCR/ddPCR, ELISA, ECLIA, immunoassays, LC-MS/MS, etc.). Extensive experience managing CROs, including method development, qualification/validation, and sample analysis. Strong knowledge of GLP/GCP and regulatory expectations for bioanalytical assays supporting gene therapy programs (FDA/EMA/ICH). Experience authoring bioanalytical strategy in regulatory submissions. Excellent leadership, communication, and vendor management skills; ability to drive execution through external partners. Previous experience with
AAV or other gene therapy platforms strongly preferred . What We Offer
Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to how we can improve our efforts A culture inspired by our values: put patients first; think independently; be radically transparent; every minute counts; and let the science speak Collaborative business environment Excellent compensation package (Base, Performance Bonus, Equity) Excellent benefits package Flexible PTO A fast-paced, data-driven, work environment with world-class R&D minds and capabilities Work with the most productive groups of R&D operators in the industry A platform for meaningful scientific contributions to shine At GondolaBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits.
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This role description has been refined for clarity and compliance. The following content reflects responsibilities, qualifications, and compensation information relevant to the position. Base pay range
$190,000.00/yr - $250,000.00/yr Company Background GondolaBio is a collection of biopharmaceutical companies focused on developing next-generation therapeutics for genetic diseases. Originally carved out of BridgeBio, GondolaBio secured $300M in private financing from external investors in 2024 and became an independent company within the BridgeBio ecosystem. GondolaBio aims to leverage cutting-edge biological research to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases. GalactaBio is a preclinical stage biotechnology company developing a novel potential best-in-class AAV gene therapy for classic galactosemia, a severe genetic metabolism disorder. Who You Are We are seeking an experienced
Principal Scientist/Associate Director in Bioanalytical Sciences
to lead bioanalytical strategy and execution for our
AAV-based gene therapy asset for the treatment of classic galactosemia . This individual will play a key leadership role in overseeing bioanalytical and biomarker method development, qualification, and validation through
effective CRO management
and cross-functional collaboration. The ideal candidate brings deep expertise in bioanalytical sciences for gene therapy, strong vendor management skills, and experience contributing to regulatory filings. Responsibilities
Lead the design and execution of bioanalytical strategies for AAV gene therapy programs, spanning preclinical through clinical development. Oversee and manage CROs/contract labs performing bioanalytical assays (qPCR/ddPCR, ELISA, ECL, LC-MS/MS, NGS, etc.) for biodistribution, pharmacokinetics, pharmacodynamics, immunogenicity, and biomarker assessments. Provide scientific and technical oversight of assay development, validation, and sample analysis at CROs to ensure regulatory compliance (GLP/GCP). Serve as the primary point of contact between internal teams and CRO partners to ensure quality, timelines, and deliverables. Partner with preclinical, clinical, and regulatory colleagues to integrate bioanalytical data into study design, data interpretation, and regulatory submissions (e.g., IND, CTA, BLA). Author/review bioanalytical sections of protocols, validation reports, study reports, and regulatory filings. Monitor emerging regulatory guidance in gene therapy bioanalytics and ensure alignment of internal and CRO practices. Travel: up to 20% of time Education, Experience & Skills Requirements
Ph.D. in Molecular Biology, Biochemistry, Pharmacology, or related discipline with
8+ years
of industry experience in bioanalytical sciences; or M.S. with
10+ years . Demonstrated expertise in nucleic acid and protein bioanalytical methods (qPCR/ddPCR, ELISA, ECLIA, immunoassays, LC-MS/MS, etc.). Extensive experience managing CROs, including method development, qualification/validation, and sample analysis. Strong knowledge of GLP/GCP and regulatory expectations for bioanalytical assays supporting gene therapy programs (FDA/EMA/ICH). Experience authoring bioanalytical strategy in regulatory submissions. Excellent leadership, communication, and vendor management skills; ability to drive execution through external partners. Previous experience with
AAV or other gene therapy platforms strongly preferred . What We Offer
Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to how we can improve our efforts A culture inspired by our values: put patients first; think independently; be radically transparent; every minute counts; and let the science speak Collaborative business environment Excellent compensation package (Base, Performance Bonus, Equity) Excellent benefits package Flexible PTO A fast-paced, data-driven, work environment with world-class R&D minds and capabilities Work with the most productive groups of R&D operators in the industry A platform for meaningful scientific contributions to shine At GondolaBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits.
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