Analytical Development Scientist / Sr. Scientist
We seek an Analytical Development Scientist/Sr. Scientist to join our CMC team. In this important role, your creativity and innovative design, development and execution expertise in assay/analytical development for biologic products will be critical to helping us take 4D to the next level. You will develop assays for release, advanced characterization, stability, comparability, and process development support for novel AAV vector products. Your analytical biochemistry, knowledge of protein and DNA structure and characterization, and strong technical writing expertise will enable your significant contributions to our talented team. This is an opportunity to join a well-funded, rapidly growing pre-IPO company as a key member of the CMC team. You will be involved in the build-out and equipment decisions for a new, expanded Analytical Lab, and have the opportunity to work on both protein- and DNA-based assays for AAV products. The size and complexity of AAVs makes them a very interesting analytical challenge, with much work to be done on advanced characterization to advance the field. This position gives the opportunity to work on cutting edge science (with opportunities to present and publish) and to make important contributions to IND filings for novel therapeutics.
- Demonstrates innovative design, development and execution of analytical projects through literature review and scientific teamwork. Leverages strong understanding of analytical biochemistry, including DNA-based assays (qCPR/ddPCR/NGS) and/or protein based assays (HPLC, electrophoresis, ELISAs, CE) as well as 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). May work with CROs 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 assay development, including DNA-based assays (qCPR/ddPCR/NGS) and/or protein based assays (HPLC, electrophoresis, ELISAs, CE) and cell-based assays
- Strong background in assay qualification/validation
- 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 multi-task and support more than one project simultaneously
- 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 skills, analytical and problem solving 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
We are 4D Molecular Therapeutics (4DMT) -- 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. 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.
While AAV gene therapy pioneers are making great strides with the first wave of products, hurdles still exist with the use of 1st & 2nd generation vectors (naturally occurring primitive viral capsids). 4DMT’s next-generation Therapeutic Vector Evolution platform generates targeted, optimized and proprietary AAV vectors that have the potential to overcome the delivery and immunological challenges currently facing the field, ultimately unlocking the full potential of gene therapy.
We invite all of you who share our passion and vision in creating the ultimate gene therapy products to cure severe genetic and rare diseases with high unmet medical need. We seek the best people in the industry who identify with our mission and innovative results-driven approach. We offer an inspiring and collaborative environment that encourages individual contributions, recognizes performance in multiple ways, offers uniquely generous benefits and provides challenging opportunities for career development.