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Facilities Engineer

Employer
4D Molecular Therapeutics
Location
Emeryville, California
Start date
Feb 12, 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:

  • This is an individual contributor role within the Facilities & Engineering group of 4DMT, which maintains R&D and cGMP biopharmaceutical manufacturing facilities located in Emeryville, CA,.
  • The Facilities Engineer reports to the Sr. Manager, Facilities and Engineering, and will take ownership of 4DMT buildings, equipment, and process engineering efforts, as well as support infrastructure and equipment maintenance activities.
  • This role requires a highly skilled, versatile, and hands-on Engineer with strong troubleshooting and problem-solving skills, and expertise across multiple technical disciplines.

RESPONSIBILITIES:

Facilities and Engineering Lead - 75% of TIME

  • Take ownership of lab equipment operations to ensure proper installation and maintenance.
  • Support planning and lead technical projects for facility construction and improvements.
  • Support facility infrastructure maintenance and calibration activities.
  • Serve as subject-matter expert in a variety of technical disciplines and subjects.

Team & Cross-functional Leadership - 25% of TIME

  • Support site safety programs, including emergency response, and construction safety programs.
  • Work in close collaboration with R&D, AD/PD, and cGMP manufacturing, ensuring facility readiness for research and production.
  • Executes policies and procedures for the Facilities and Engineering function.

QUALIFICATIONS:

Education:

  • Bachelor’s degree (minimum) in a relevant Engineering discipline or other technical field, or vocational training or equivalent skilled-trades or military education and field experience, sufficient to perform the required duties at the level of performance expected.
  • Advanced degree not required.
  • Former military personnel with a technical background in equipment, facility, or ship maintenance are encouraged to apply.
  • Relevant professional certifications and credentials are a plus, but not required:

General Experience:

  • Minimum 3 years field experience as a hands-on engineer performing equipment and systems troubleshooting, installation, commissioning, or maintenance, in an industrial, laboratory, or commercial setting.
  • Some experience with facility mechanical systems (HVAC, refrigeration, boilers) sufficient to recognize faulty performance, diagnose issues, and perform basic equipment maintenance and operations.
  • Experience in biotech/pharmaceutical operations ((MP facilities, cleanrooms, aseptic processing) is a plus, but not required.

Skills, Expertise, and Knowledgebase (preferred, but not all required for this position):

  • Equipment and Facility Engineering:
    • Design, build, programming, integration, commissioning, & troubleshooting of industrial capital equipment, automated machinery, industrial control systems, process instrumentation, and\or factory automation systems.
    • Experience with 24vdc industrial controls, building automation systems, and industrial PLCs, and producing electrical schematics, controls drawings, and Piping and Instrumentation Diagrams (P&ID) using AutoCAD.
    • Critical facilities design and high-reliability\high-uptime operations and maintenance for data centers, pharmaceutical\biotech labs, or civic facilities.
    • Practical knowledge of industrial components and their applications (electrical components, fasteners, NPT and tube fittings, etc.) and the safe operation of powered hand tools.
  • Infrastructure Maintenance:
    • Industrial equipment wiring and familiarity with safety principles (e.g., Lockout\Tagout), and methods and practices for diagnosing, repairing, and installing120/208/480vac single and multiphase industrial equipment.
    • Facility systems
      • Packaged air-handlers and HVAC systems,
      • Gas-fired boiler operation and HHW distribution
      • CDA compressors, dryers, and associated pneumatic controls,
      • VFD-driven pumps and motors.
    • Project Management:
      • Developing project requirements and specifications.
      • Technical writing for SOPs, safety protocols, training modules, and work instructions.
      • Materials inventory control and BOM development
    • Other
      • Ability to read and interpret technical manuals, schematics, P&ID diagrams, blueprints, and other technical literature.
      • Knowledge of relevant industry standards, tools, and software.
        • NEC, ANSI, GMP, ISO standards
        • AutoCAD, BMRAM CMMS, eTAP, MS Project, software

Physical Requirements of the Role:

(more information on examples - https://tmhra.org/ADAToolkit/5-WriteADA-JobDescrip.pdf )

  • Expectation to be onsite at 4DMT Emeryville location 80% of the time.
  • Must be able to lift 25 lbs without assistance and will require the ability to bend, lift, and twist on a daily basis.
  • Tasks require working outside in any weather, in tight or confined spaces, and including elevated areas only accessible by ladder.
  • Role will require accessing GMP cleanrooms which requires ability to wear and work within protective gowning.
  • Ability to wear PPE (steel-toed boots, safety glasses, ear plugs, work gloves, etc.) and be aware of safety annunciations (audio and\or visual alarms, oxygen monitoring displays, etc.).
  • Communication skills, both written and verbal, including sufficient ability to read and understand technical manuals and safety information.
  • All staff are required to adhere to all 4DMT health and safety policies. Workplace may require Staff to be vaccinated or subject to other medical surveillance.
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
US

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