What are the responsibilities and job description for the Associate Scientist II - Analytical Development position at GondolaBio LLC?
Job Description
Job Description
Description : About GondolaBio
GondolaBio is a clinical-stage biopharmaceutical company focused on developing next-generation therapeutics for genetic diseases. Originally launched as BridgeBioX, a subsidiary of BridgeBio, GondolaBio secured $300M in private financing from external investors in 2024 and became an independent company within the BridgeBio ecosystem. The company aims to leverage cutting-edge biological research to create breakthrough medicines addressing high unmet needs across multiple therapeutic areas, including neurology, pulmonology, cardiology, nephrology, and endocrinology. Located on the Stanford Life Sciences campus, GondolaBio fosters a unique hybrid environment where top scientists from around the world collaborate with senior leadership and advisors, blending industry expertise with academic innovation.
About BridgeBio
BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 20 drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.
Our focus on scientific excellence and rapid execution aim to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe.
To learn more about our story and company culture, visit us at https : / / bridgebio.com
Who You Are
The Associate Scientist II will be a member of the Analytical Development team within the Technical Development and Operations function. The primary focus of the position is driving analytical method readiness and performing cGMP lot release and stability testing for the manufacture of AAV-based gene therapies. The scope of the role also includes technical document authoring, method optimization, and method transfer as programs move to later clinical stages. This individual will collaborate closely with the Quality, Laboratory Operations, and Process Development functions to ensure early-phase analytical methods are in a state of compliance and appropriately support the cGMP manufacture of AAV-based gene therapies.
Requirements : Responsibilities
- Perform routine testing for both GMP and non-GMP samples in support of cGMP manufacture and process development.
- Execute qualification assays per pre-approved protocols.
- Author test methods and qualification protocols / reports.
- Collaborate with the Quality group to ensure test methods and equipment are maintained in compliance with early-phase GMP release testing.
- Manage the transfer of qualified assays to 3rd party testing sites.
- Actively work to minimize assay turnaround times while prioritizing work according to program needs to make sure timelines are met.
- Contribute to the execution of experiments for qualitative and quantitative characterization of recombinant AAV-based gene therapy candidates.
- Troubleshoot instrumentation and analytical testing methods when necessary. Support laboratory operations including instrument maintenance and supplies management.
- Ensure all experimental procedures and documentation are compliant with highest quality and regulatory standards.
- Document experimental data, results, and conclusions in the appropriate lab notebook for the test being performed for GMP release / stability testing, method qualification, and routine development and PD support.
Qualifications and Skills
What We Offer