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Material Planner

Employer
4D Molecular Therapeutics
Location
Emeryville, California
Start date
Feb 9, 2024

Job Details

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 Supply Chain team lead, this role plays a critical role in managing the supply of required materials to support early to late phase clinical manufacturing needs while maintaining targeted inventories, in a complex bio-pharmaceutical environment. Working closely within the Supply Chain team, as well as cross-functionally with Manufacturing, Quality Control, and Quality Assurance, this position takes a key role in drafting purchasing plan based on list of materials required for scheduled clinical production, procuring according to plan, coordinating and overseeing delivery, and ensuring materials are promptly released internally.  

This role is expected to be onsite 5 days a week. 

 RESPONSIBILITIES:  

The objective of the Material Planner is to develop supply plan, taking into accounts of forecasts, availability of materials, and manufacturing schedule, execute on the plan to ensure that materials are available and internally released at the right time for scheduled activities. The Material Planner will also assist in improving the material planning functions through oversight of external testing labs used for incoming material release. 

 Planning and Procurement: 60% of TIME 

  • Draft purchasing plan based on clinical forecast and manufacturing schedule 
  • Submit Order Requisitions based on established plans 
  • Resolve issues that may arise from order placement, PO acceptance, and delivery of products 
  • Coordinate and schedule delivery of materials  
  • Active review Bill-of-Materials to ensure information is accurate and consistent with actual usage 
  • Establish and maintain relationships with suppliers and vendors 
  • Identify potential suppliers secondary or backup as needed 
  • Track and report material readiness on a routine basis  
  • Inform stakeholders of any delays in ordering and delivery timeline that may have an impact on scheduled manufacturing activities 

 Inventory Oversight: 25% of TIME 

  • Establish inventory best practice parameters such as safety stock, reorder point and Kanban or Min/Max levels based on actual usage 
  • Contribute to the lifecycle management process to optimize inventory, mitigate material expiration and reduce scrap. 

 MFGSC supports: 15% of TIME 

  • Coordinate miscellaneous material requests from cross-functional team to support non-manufacturing projects 
  • Participate in continuous improvement projects 
  • Other duties as assigned 

QUALIFICATIONS: 

Education: 

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

Experience: 

  • 3+ years of experience in manufacturing or supply chain management function within the Biotech or similar industry.  
  • Experience in cGMP environment is preferred.  
  • Experience in developing and implementing processes, procedures, and systems preferred.  
  • Certification such as CPIM is desirable. 

Skills: 

  • Intermediate/Advanced knowledge of Microsoft Suites 
  • Proficiency with ERP/MRP systems, or materials planning in Excel formats 
  • Experienced in data modeling, production planning, or materials planning 
  • Must be flexible and adaptable in a fast-paced environment while being organized 
  • Able to manage multiple projects/tasks simultaneously 
  • Solid written and verbal communication skills  
  • Excellent interpersonal and communication skills  
  • Positive attitude with a strong desire for continuous learning 

 Hourly Rate: $ 38.94/hr - $ 48.07/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

Company

4DMT is a gene therapy company with a transformative discovery platform --Therapeutic Vector Evolution --that enables our “disease first” approach to product discovery and development, thereby allowing us to customize our AAV vectors to target specific tissue types associated with the underlying disease.


At 4DMT we are creating and developing optimized “biopharmaceutical grade” AAV vectors that will allow us uniquely to unlock the full potential of gene therapy. Our customized and proprietary AAV vectors are each designed, according to a 4DMT Target Vector Profile, to deliver genes to specific cells and tissues in the body to eradicate both rare and large market diseases.


While AAV gene therapy pioneers are making great strides with the first wave of products, hurdles still exist with the use of conventional vectors. The most commonly used AAV capsids (e.g., AAV2, 5, 8 and 9) were identified either 1) as contaminants in lab stocks of adenovirus, or 2) through monkey tissue processing. Therefore, these conventional vectors are not targeted specifically to any tissue in the body. This can lead to inefficient and non-specific delivery, thus requiring extremely high doses and potentially resulting in toxicities (including inflammation), high manufacturing burdens and suboptimal efficacy. In addition, suboptimal routes of delivery can be required for delivery to the right tissues (e.g., subretinal delivery to the retina). Finally, pre-existing neutralizing antibodies in many patients can limit efficacy, clinical trial enrollment and market sizes. 4DMT Innovation empowers us to create new and improved next generation AAV capsids to allow targeted delivery of our products by the optimal clinical route of administration.


At 4DMT we use our robust discovery platform, termed “Therapeutic Vector Evolution,” to create customized and proprietary gene delivery vehicles (novel AAV vectors) to deliver genes to specific tissues and cells in the body by the optimal route of administration. We use the power of evolution to create and refine these optimized vectors through genetic diversification and then natural selection in vivo.


4D Purpose Statement:  Boldly Innovating to Unlock the Full Potential of Gene Therapy for Countless Patients


GUIDING PRINCIPLES

 

  • Dare to Cure - Patients are waiting. Create big dreams for patients and take calculated risks to achieve them
  • Break Boundaries - Question the status quo and innovate beyond conventional approaches
  • Beyond Yourself - It's about patients, their families, our team, our families. We strengthen each other.
  • Prepare and Execute Relentlessly - Start with the end in mind, over-prepare and make contingency plans to your contingency plans


We invite all of you who share our passion and vision in creating the ultimate gene therapy products to cure genetic and rare diseases in children and adults. 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 generous benefits and provides challenging opportunities for career development. 
 

Company info
Website
Phone
510-505-2680
Location
5858 Horton St. Suite 455
Emeryville
California
94608
United States

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