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 Associate Scientist/Scientist, Purification & Formulation Development to join our leading-edge Downstream Process Development team in developing formulations and processes for novel AAV vectors.
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 purification and formulation development will be critical to helping us take 4DMT to the next level. Your work will directly impact both Process Development and Manufacturing. This role will require close collaboration with the Analytical Sciences & Bioinformatics (ASB) team.
This is an opportunity to join a rapidly growing pre-IPO company as a key member of the process development team. You will be involved in the build-out and outsourcing decisions for a new, expanded process development laboratory, and have the opportunity to work on many products across multiple therapeutic areas. The diverse nature of our 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 accelerate the delivery of high-value therapeutics to patients. Moreover, you will have opportunities to present and publish as well as to make important contributions to regulatory filings for novel therapeutics.
- Leverages strong understanding of biophysical characterization techniques (including DLS, DSC, CE and HPLC-based methods, UV, and AUC) for pre-formulation studies. Designs, executes and interprets experimental data.
- Responsible for management of outsourced formulation studies, working with CROs.
- Develops formulations based on physiochemical information derived from pre-formulation studies to support the needs for drug delivery. Works closely with project leads to define deliverables and project timelines.
- Responsible for IND-enabling characterization of therapeutic and reporter viral transgenes, using a variety of methodologies to test for product stability and comparability.
- Work with Process development team to develop and scale-up multi-step purification process for the production of AAV variants. Applies knowledge derived from pre-formulation studies to aid in appropriate buffer and excipient selection.
- Authors SOPs and technical reports, presents experimental data in project and group meetings.
- Demonstrates innovative design, development and execution of projects through literature review and scientific teamwork. Reviews data and supports troubleshooting issues that occur during development, scale-up, and manufacturing.
- 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.
KNOWLEDGE AND SKILLS:
- A Ph.D. in Biochemistry, Chemical Engineering, or related scientific field is preferred. A minimum of 2 years’ work experience in drug product development is required. Exceptional MS or BS candidates with demonstrated capabilities in process development and formulation will be considered (e.q. MS with >6 years, B.S. with >10 years)
- Must have a solid understanding of formulation development for biologics (AAV preferred), protein chemistry, and experience with standard analytical characterization techniques (DLS, DSC, IEC, HPLC, particle characterization)
- Working knowledge in design of experiments (DoE) and associated software
- Skilled in the art of protein purification techniques including column chromatography, filtration, and TFF
- Working knowledge of AKTA chromatography system with Unicorn Software or alternate system
- Experience working with external vendors and CROs is desirable
- 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
- Strong organizational skills, analytical and problem-solving skills
- Strong written and oral communication skills, 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