Specialist, Materials Management

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 SUMMARY: 

Reporting to the Manager, Materials Management, this role is expected to work closely with the Supply Chain team, as well as cross-functional groups such as Facilities, Quality, Process Development, Quality Control, and Manufacturing for the successful execution and oversight of all raw material testing and release, as well as vendor providing testing services. This role is also responsible for managing change related to materials and vendors with internal and external teams. There would be a significant amount of learning opportunities associated with implementing new processes and systems. 

This role is expected to be onsite 5 days a week, with some of the time spent in a warehouse setting performing warehousing and inventory control duties. 

 RESPONSIBILITIES:  

The objective of the Specialist, Materials Management, is to oversee GMP material receiving, testing, release, and transfer between sites, as well as assessment of inventory levels across various storage locations in close proximity. This role works closely with PD and Manufacturing to provide potential options, availabilities, and lead-time for newly introduced materials, and with Analytical groups for material coordination and transfer. 

Inventory Management/ Material Control: 60% of TIME 

• Prepare test samples and send to external testing labs as part of incoming material release workflow 
• Coordinate and schedule internal and external testing needs to ensure materials are promptly released per specifications 
• Perform first- pass in external data review before passing on for quality review 
• Manage vendor and material changes appropriately per internal procedure 
• Conduct Bill of Material review with Manufacturing and PD, communicate changes that may impact campaign readiness, and influence use of alternative as applicable  
• Monitors inventory levels and usage of material 
• Perform material issuance to various functional team and replenish general consumables as needed  
• Responsible for routine cycle count of GMP inventory to maintain inventory accuracy 
• Support inventory review and root cause analysis 
• Assist other team member in implementation of new system or improvements  

GMP material receipt, and release: 25% of TIME 

• Work with other SC team member to ensure materials are received and stored appropriately  
• Works with various groups to resolve discrepancies discovered during the receipt/inspection process. 
• Responsible for prompt release of materials for clinical manufacturing, or for other projects as requested 
• Ensure accurate GMP records are maintained at all times 

GMP document support: 15% of TIME 

• Draft or review material specifications and conduct periodic assessment to ensure accuracy of effective documents. 
• Update function specific Standard Operating Procedure as needed 
• Provide receive and release documentation for IND filing as needed 

• Other duties as assigned 

QUALIFICATIONS: 

Education: 

• Bachelor’s degree in Supply Chain or biological discipline 
• Supply Chain Certification such as CPIM is preferred 

Experience: 

• 4 years working in an FDA regulated GMP environment with a clear understanding of inventory management 
• Familiarity with inventory control systems and computer office programs (Microsoft Office).  

Skills: 

• Intermediate/Advanced knowledge of Microsoft Suites 
• Knowledge of Material Control operations and procedures associated with the stockroom, shipping and receiving 
• Solid written and verbal communication skills  
• Excellent interpersonal and communication skills  
• Positive attitude with a strong desire for continuous learning 

 Hourly Rate: $ 39.42/hr - $ 47.12/hr 

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

About the Company:
4D Molecular Therapeutics