Senior Scientist, Analytical Development and Quality Control

Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your ability to work with 4DMT in the future.

 

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 SUMMARY: 

We are seeking a highly skilled and motivated Senior Scientist to join our Analytical Development and Quality Control (ADQC) team. This individual will help lead the efforts for development of analytical procedures in support of product and process characterization. This position requires a strong background in analytical chemistry, molecular biology, or a related field, along with extensive experience in the biotechnology or pharmaceutical industry. 

KEY RESPONSIBILITIES:  

• Develop, optimize, and validate analytical methods for the characterization and quality control of AAV vectors, including purity, identity, and advanced characterization. 

• Perform and oversee complex analytical testing techniques such as ddPCR, UPLC, capillary electrophoresis, and various spectroscopic methods. 

• Design and execute experiments to support process development, formulation development, and stability studies of AAV products. 

• Lead method transfer activities to internal and external laboratories, ensuring robust and reproducible performance. 

• Interpret and analyze data, providing clear and concise reports and presentations to cross-functional teams and stakeholders.  

• Mentor and provide technical guidance to junior scientists and laboratory staff.  

• Collaborate with colleagues in Research, Process Development, Quality Control, and Regulatory Affairs to ensure alignment and successful project outcomes. 

• Stay current with industry trends, regulatory guidelines, and advancements in analytical technologies, particularly those related to AAV gene therapy 

QUALIFICATIONS: 

Education & Experience: 

• Ph.D. in Analytical Chemistry, Molecular Biology, or a related field with 5+ years of relevant experience; or M.S. with 8+ years of relevant experience; or B.S. with 10+ years of relative experience in the biotechnology or pharmaceutical industry.   

• Proven expertise in developing and validating analytical methods for gene therapy products, particularly AAV vectors 

• Hands-on experience with a wide range of analytical techniques, including ddPCR, chromatography, electrophoresis, and spectroscopy. 

• Strong understanding of regulatory requirements and guidelines for analytical method development and validation (e.g., ICH, FDA, EMA).  

• Excellent problem solving skills and the ability to work independently and collaboratively in a fast-paced environment. 

• Strong organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously.  

• Effective communication skills, both written and verbal, with the ability to convey complex technical information to diverse audiences.  

• Experience with the development of analytical methods in relation to biophysical and physiochemical characterization  

Preferred Qualifications: 

• Experience with analytical method development for AAV vectors or other viral vectors.  

• Knowledge of statistical software and tools for data analysis. 

• Familiarity with automated and high-throughput analytical techniques.  

• Proficient with Microsoft based Windows programs: Word, Excel and PowerPoint  

Compensation Range:

$164,000/yr - $194,000/yr

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.   Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities