Research Associate II, Downstream
4D Molecular Therapeutics
At 4D Molecular Therapeutics, Inc. (“4DMT”), we boldly innovate to unlock the full potential of genetic medicines for countless patients. We are committed to breaking boundaries and daring to cure as we develop new and foundational products and product components through our growing technology platforms.
4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines. We seek to unlock the full potential of gene therapy using our platform, Therapeutic Vector Evolution (TVE), which combines the power of directed evolution with our approximately one billion synthetic AAV capsid-derived sequences to invent evolved vectors for use in our products. We believe key features of our targeted and evolved vectors will help us create targeted product candidates with improved therapeutic profiles. These profiles will allow us to treat a broad range of large market diseases, unlike most current genetic medicines that generally focus on rare or small market diseases.
We have built a deep portfolio of AVV-based gene therapy product candidates, with five product candidates in clinical trials: 4D-150 for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), 4D-710 for the treatment of cystic fibrosis lung disease, 4D-310 for the treatment of Fabry disease cardiomyopathy, 4D-125 for the treatment of X-linked retinitis pigmentosa (XLRP), and 4D-110 for the treatment of choroideremia. In addition, we have two product candidates in preclinical studies: 4D-175 for geographic atrophy (GA) and 4D-725 for alpha-1 antitrypsin deficiency.
To-date, we have demonstrated clinical proof-of-concept for three evolved vectors in three therapeutic areas and routes of administration with five products and patient populations. We believe this validates the power of our directed evolution platform for discovering superior vectors compared to wildtype viral vectors. We have built a robust and efficient product engine with 6 open Investigational New Drug Applications (INDs) in the U.S., 1 IND in Taiwan, and 1 Clinical Trial Approval (CTA) in Australia. We believe we are positioned to create, develop, manufacture and, if approved, effectively commercialize targeted genetic medicines that could transform the lives of patients suffering from debilitating diseases.
In addition to TVE, our technology includes a robust AAV manufacturing platform and onsite manufacturing facility that allows us to rapidly produce and test research grade material and scale up to GMP clinical material. This internal capability and close collaboration between our R&D and Manufacturing teams has greatly accelerated the pace of discovery at 4DMT.
Company Differentiators:
• Fully integrated clinical-phase company with internal manufacturing
• Demonstrated ability to move rapidly from idea to IND
• Five candidate products in the clinic and two declared pre-clinical programs
• Robust technology and IP foundation, including our TVE and manufacturing platforms
• Initial product safety and efficacy data substantiates the value of our platforms
• Opportunities to expand to other indications and modalities within genetic medicine
GENERAL ROLE DESCRIPTION:
The 4DMT technical operations team is looking for a motivated individual to assist in executing experiments designed to improve downstream process knowledge. You will be working onsite within a small team of scientists to innovate, design, and perform tests involved in AAV purification. Our department works closely with that of research, upstream, analytical, and manufacturing to advance gene therapy products to market. This position allows for an opportunity to develop novel strategies, to work in a fast paced environment, and to expand purification process knowledge.
PRIMARY RESPONSIBILITIES:
Lab & Experimental Activities: 70% of Time
- Design and execute studies that advance process knowledge of key downstream chromatography steps with consideration of increased AAV yield and purity
- Utilize data analysis tools and employ critical thinking to implement process changes
- Assist in Technical Transfers of methods from process development to manufacturing departments
- Assist in innovation to improve purity and yield of AAV products
- Routine production of AAV capsids for inter-departmental product improvements
- Assist in the production of research grade and GLP grade AAV material
- Generate data for characterizing Phase 1-3 processes with reportable NORs and PARs
- Assess and address current process gaps to improve product quality
Cross-functional & Communication: 30% of Time
- Collaborate with process & analytical teams to screen and evaluate drug candidates across a range of indications
- Organize and maintain data in project reports and electronic notebook
- With guidance, prioritize and communicate experiment timeline outlooks
- Review and present data to process team and at cross-functional department forums
- Maintain current awareness of scientific literature
- Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time
- Meta Data Analysis for tracking and tracing changes in our processes
QUALIFICATIONS:
Education & Experience:
- BS with 2-4 years or MS with 2-3 yrs relevant experience in Biochemistry, Chemistry, molecular biology, virology or other relevant field.
- 2+ Industry Experience required
- Hands-on experience with column purification techniques
Skills: (non-technical and technical skills)
- Phase 3 process development experience preferred
- Knowledge and demonstration of buffer preparatory skills are required
- Practical Experience with Unicorn software or equivalent chromatography software is required
- Experience writing laboratory notebook reports and protocols required
- Strong oral and written communication skills
- Able to handle multiple projects with priority guidance
- Demonstrates organized data management
- Familiarity with Excel, Word, and PowerPoint are required, and basic statistical analysis techniques
Bay Area base salary compensation range is $85,000 - $101,000.
Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.