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Research Associate II, Assays

Employer
4D Molecular Therapeutics
Location
Emeryville, California
Start date
Nov 2, 2022

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Job Details

4D Molecular Therapeutics, Inc. (“4DMT”) is a clinical-stage gene therapy company pioneering the development of product candidates using targeted and evolved AAV vectors. 4DMT seeks to unlock the full potential of gene therapy using its platform, Therapeutic Vector Evolution, which combines the power of directed evolution with approximately one billion synthetic capsid sequences to invent evolved vectors for use in targeted gene therapy products. The company is initially focused in three therapeutic areas: ophthalmology, cardiology, and pulmonology. The 4DMT targeted and evolved vectors are invented with the goal of being delivered through clinically routine, well-tolerated and minimally invasive routes of administration, transducing diseased cells in target tissues efficiently, having reduced immunogenicity and, where relevant, having resistance to pre-existing antibodies. 4DMT has five active clinical trials: 4D-150 is a Phase 1/2 clinical trial for Wet AMD, 4D-125 is in a Phase 1/2 clinical trial for XLRP, 4D-110 is in a Phase 1 clinical trial for Choroideremia, 4D-310 is in a Phase 1/2 clinical trial for Fabry disease and 4D-710 is a Phase 1/2 clinical trial for Cystic Fibrosis.   4DMT is focused on attracting and retaining 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 competitive salary and benefits, and provides challenging opportunities for career development.  4D Molecular Therapeutics is located in Emeryville, CA. General Summary

4DMT needs a motivated, detail-oriented, and experienced Research Associate 2. This individual will join a growing Cell-Based Assay (CBA) team to develop, optimize and validate cell-based bioassays for the characterization, lot release/stability testing and formulation assessment of AAV-based gene therapy drug substances and drug products. Working cross functionally with Research, Discovery, Process Development, Manufacturing, Quality, and Facilities the Research Associate II will support the life cycle of bioassays for current and new candidates during early- and late-stage GMP production.

Responsibilities

Lab work/experimental/data analysis 70% of TIME

  • Maintain cell lines, prepare, and qualify cell banks using aseptic techniques with emphasis on adherent mammalian cell culture systems.
  • Develop, optimize, and execute bioassays including cell-based, nucleic acid-based, ELISA, and enzymatic assays with a strong scientific understanding of the analytical procedures and applicability of the emerging or existing assay platforms.
  • Understanding phase appropriate GMP requirements for AAV based gene therapy products.
  • Perform under limited supervision routine testing of samples for characterization, Process Development support, and QC release/stability purpose.
  • Provide feedback and/or suggest modifications to operational procedures.
  • Assist with troubleshooting of analytical procedures and equipment problems; work with Facilities to assist with calibration, maintenance, and operation requirements of analytical equipment.
  • Assist with the new facility expansion and equipment validation activities as needed.

Paperwork/documentation 30% of TIME

  • Complete and submit experimental records following Good Documentation Practices, cGMP, and corporate policies to meet both operational and compliance requirements.
  • Contribute to experimental protocols, reports, internal documents including SOPs, lab records, deviations, and investigations as appropriate.
  • Maintenance of lab inventories and update database for designated project(s).
  • Work closely with supervisors and cross-functional teams for setting up and following the testing schedule to meet timelines for products release, stability, and characterization purposes.
  • Work closely with Materials Management to keep the reagents and lab supplies inventory stocked properly and within expiration.
  • Follow all Quality and Safety procedures, including deviation and non-conformance reporting. Support deviation investigations and lab maintenance.
  • Other Duties as Assigned.
Qualifications
  • Bachelor’s degree in a relevant area of life sciences specialization (bioprocessing, chemical engineering, biochemistry, cell/molecular biology or similar).
  • 2+ years of experience with Cell based assays and analytical procedures
  • Exposure to Quality Control Processes/Regulations - Preferred
  • Ability to adapt and work in a small company environment.

Required Skills:

  • Proficiency with Cell/Tissue culturing and aseptic techniques.
  • General understanding of molecular, cell and/or viral biology.
  • Hands-on experience and strong understanding of the technical concepts in immunoassay (Western Blotting, ELISA) and molecular based techniques such as ddPCR.
  • Attention to detail, quality, and compliance with strict adherence to test procedures and protocols.
  • Ability to learn new technologies and processes in a timely manner.
  • Must be a team player with analytical mindset, detail-oriented critical thinker, exhibit a readiness to meet project timelines and challenges in a dynamic fast-paced environment.
  • Strong written and oral communication skills with demonstrated ability to present scientific ideas and information and data effectively via one-on-one discussions and team meetings.
  • Basic math and familiarity with Excel, Word, and PowerPoint.

Preferred Skills:

  • Cell-based potency assays experience in the AD/QC environment.
  • Hands-on experience with SDS-Page/Western Blot, protein-protein interactions, and flow cytometry.
  • Experience in the development of new methods and sound scientific understanding of Quality by Design (QbD) and Design of Experiments (DoE) principles as well as data analysis and statistics.
  • Experience with bioassay and/or statistical software such as SoftMax Pro, PLA, GraphPad, Minitab, JMP or Spotfire.
  • Working knowledge of regulatory and industry guidelines in CMC analytical development.

Reports to: Sr. Scientist, Cell-Based Potency Assays AD/QC

Physical Requirements:

  • Capable of repetitive work (pipetting/liquid transferring).
  • Ability to lift, dispense, push and/or pull items with an average weight of 25 pounds.
  • Ability to sit or stand for extended periods of time and intermittent walking to gain access to work areas.
  • Ability to use a computer, hard copy materials and to complete paperwork activities (finger dexterity, vision).
  • Hearing sufficient to communicate with individuals by telephone and in person.
  • May be required to work during non-regular hours.
  • Capable to be tested for COVID-19 and adhere to 4DMT Covid protocols and policy.
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       Attention: Search Firms / 3rd Party Recruitment Agencies* The Talent Acquisition / HR team manages the recruiting for all positions at 4D Molecular Therapeutics. We will only accept resumes from a search agency/recruiter if we have a signed agreement in place and the Talent Acquisition / HR team has formally requested your help on a specific role. Unsolicited resumes sent to 4D Molecular Therapeutics will be considered property of 4D Molecular Therapeutics. 4D Molecular Therapeutics will not be responsible for any fees associated should we hire from unsolicited resumes.   Recruiters are requested not to contact or present candidates directly to our hiring managers or employees, and doing so may jeopardize eligibility to work on future positions. Recruiters interested in working with 4D Molecular Therapeutics can submit their information to recruiting@4dmt.com– should we have a tough-to-fill role, we will contact you directly if you specialize in that area.

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. 
 

Find Us
Website
Phone
510-505-2680
Location
5858 Horton St. Suite 455
Emeryville
California
94608
US
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