Homeoffice GondolaBio Service Co, Inc. - Principal Scientist/Associate Director, Bioanalytical Sciences bei GondolaBio Service Co, Inc.

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. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. GondolaBio is a multi-state employer, and this salary range may not reflect positions based in other states.  

The base pay range for this position is $190,000 to $ 250,000 per year. The actual compensation offered will be determined based on a number of job-related factors, including experience, skills, qualifications, and location.  A bonus plan and equity will also be offered.