4D Molecular Therapeutics (4DMT), located in Emeryville, is a global leader in gene therapy product research and development using scientific innovation to unlock the full potential of gene therapy for patients with genetic diseases. At 4DMT, our goal is to design and develop transformative gene therapy products using our proprietary adeno-associated virus (AAV) variants platform to treat serious unmet medical conditions. We seek a talented and passionate Cell-Based Assay Scientist / Sr. Scientist to join our leading-edge Analytical Sciences & Bioinformatics (ASB) team in developing methods, algorithms and business processes for release, characterization ad process development for novel AAV vectors, with a particular focus on cell-based potency assays.
Yes, there are many gene therapy and editing companies, but 4DMT is at the forefront of cutting-edge science and technology with proprietary AAV vectors that deliver transgene payloads to the right place for patients.
Your creativity and innovative design, development and execution expertise in cell-based assays for biologic products will be critical to helping us take 4DMT to the next level.
You will work will impact R&D teams that are both up- and down-stream from ASB, including: Discovery & Engineering, Human Cell & Disease Modeling, and Process Development.
This is an opportunity to join a well-funded, rapidly growing pre-IPO company as a key member of the ASB team. You will be involved in the build-out and outsourcing decisions for a new, expanded ASB laboratory, and have the opportunity to work on many products across multiple therapeutic areas. The complex mechanism of action of AAVs, along with the high tissue specificity of our targeted AAV vectors, makes this position ideal for scientists looking to solve challenging puzzles, with much work to be done to advance the field to help more patients faster. You will work on cutting-edge science, including induced pluripotent stem cell and primary cell culture assays. Moreover, you will have numerous opportunities to present and publish as well as to make important contributions to regulatory filings for novel therapeutics.
- Demonstrates innovative design, development and execution of analytical projects through literature review and scientific teamwork. Leverages strong understanding of cell-based assays, from early development through qualification and validation. Designs, assesses and interprets experimental data.
- May manage Associates in either assay development or assay execution/routine testing. Reviews data and supports troubleshooting; manages analytical deviations.
- Leads both from the bench (hands-on laboratory work) and from the desk (designing studies, analyzing data, preparing reports and documents).
- Works directly with CROs and CDMOs on assay development and transfer.
- Writes assay development reports, assay qualification and validation protocols and reports, and regulatory documents. Authors manuscripts and presents results at appropriate scientific meetings.
- Contributes to building a culture that embraces continuous learning, improvement and innovation, and encourages team members to expand their technical skill base and deepen their gene therapy expertise. Maintains a current awareness and contributes to current scientific literature; actively applies new concepts and technologies as appropriate.
- Leads and supports research initiatives such as new technology development and continuous improvement projects.
Skills & Experience:
- PhD (Chemical engineering, Bioengineering, Biology, Biochemistry, Virology, or related field) with 2+ years’ experience, MS with 5+ years’ experience, or BS with 10+ years’ experience in analytical development/QC of large molecule or cellular therapies.
- Extensive working knowledge of cell-based assays for potency.
- Experience with stem-cell and/or primary cell culture is strongly recommended.
- Additional background in DNA and/or protein analytics for biologics is desired.
- Strong background in assay qualification/validation, with knowledge of viral gene therapy (adeno associated viral vectors) preferred.
- Experience managing Research Associates is desired but not required.
- Successful demonstrated ability to work independently and lead others in designing and developing experiments, analyzing and interpreting data in a rigorous way.
- Ability to work in a team-based environment, cooperatively and supportive of multiple viewpoints and approaches.
- Understanding and knowledge of key scientific software programs.
- Understanding and knowledge of regulatory requirements for biologic products.
- Strong organizational, analytical, problem-solving and multi-tasking skills.
- Strong communication skills, both written and oral, with demonstrated ability to present ideas and information and data effectively via one on one discussions, team meetings and partnership interactions.
Qualified candidates may submit a resume and cover letter to firstname.lastname@example.org