4D Molecular Therapeutics, located in Emeryville, CA is a global leader in gene therapy product research & development using scientific innovation to unlock the full potential of gene therapy for patients with genetic diseases. At 4D Molecular Therapeutics, our goal is to design and develop transformative gene therapy products using our proprietary adeno-associated virus variants platform to treat serious unmet medical conditions. 4D Molecular Therapeutics currently is seeking a Senior Scientist to play an integral role in developing and implementing a variety of assays needed to advance gene therapy programs into the clinic, as well as to analyze clinical samples. The Senior Scientist will lead efforts to develop biomarkers and bioanalytic assays for our programs, coordinate efforts with CROs, and be a core member of program teams.
Specific Responsibilities Include (but not limited to):
- Oversee development of biomarker and bioanalytical assays in support of in vivo pharmacology and toxicology studies from Discovery Research through human clinical trials.
- Develop robust and reliable assays suitable for characterizing proprietary lead adeno- associated virus variants and development candidates.
- Ensure efficient development and execution of assays, document methods and results in a regulatory compliant manner and critically review, interpret and analyze data for ultimate inclusion in IND-enabling study reports.
- Oversee transfer of bioanalytic methods to CRO/QC laboratories for qualification/ validation under both non-GLP and GLP environments.
- Oversee optimization, and refinement of assays for increased sensitivity, specificity, and robustness.
- Author and/or review SOPs, technical reports, and study reports.
- Present scientific results at team, staff, and company meetings.
- Represent pharmacology, toxicology and bioanalytical functional areas in product team discussions/meetings.
- PhD degree in a relevant life science discipline with at least 8 years of relevant experience in an industrial pharmaceutical/biotechnology lab setting.
- In-depth experience in assay method development, qualification, validation, tech transfer and execution (e.g., ELISA, anti-drug antibody, ELISPOT, qPCR, RT-qPCR, IHC techniques).
- Demonstrated experience working in a GLP environment.
- Demonstrated ability to work in a fast-paced, dynamic work environment.
- Previous experience managing outsourced contracts and success at documenting and administering the contract terms and requirements.
- Keen attention to detail; exceptional organizational skills.
- Excellent written and oral communication skills.
- Must be able to work independently and within team environments.
- Ability to prioritize tasks, adapt to shifting priorities, and deliver on projects in a timely manner.
- Experience working in cross-functional product development teams and, in particular, in a scientific or clinical setting is desired.
- Ability to confidently and respectfully interact with all levels of management.
- Experience in regulatory affairs, clinical operations, and/or manufacturing is additionally desirable.
- Bioinformatics and/or biostatistics experience is a plus.
Qualified candidates may submit their cover letter and resume to email@example.com for consideration