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Sr. Bioengineering Process Engineer

Employer
4D Molecular Therapeutics
Location
Emeryville, California
Start date
Sep 11, 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

We seek a talented and passionate Senior Process Development Engineer to join our leading-edge Upstream Process Development team in designing manufacturing processes and novel AAV vectors. This person will report to the head of Upstream Process Development and is responsible for leading the team maturing bioreactor processes, designing studies that evaluate transient transfection (adjuvant selection, component ratios, other critical parameters) and playing a key role in the development and characterization of clinical stage programs. They will also interact closely with the following teams: Downstream Process Development, Analytical Development, Supply Chain and Upstream Manufacturing. 

 

Responsibilities  

Planning & Experimental: 65% of time 

  • Design and execute production studies leveraging 4DMT’s vector platform processes, focusing on HEK293 cellular expansion, transient transfection and AAV production 
  • Operation and maintenance of online and offline PAT equipment; collaborate internally/externally to identify next-generation technologies 
  • Design DoE-based studies and multivariate analysis to evaluate critical process parameters to improve process yields, process consistency and product profile  
  • Understand and leverage process variables such as kLa, sparger formats, aspect ratio, tip speed and P/VL to streamline process development and scale-up to manufacturing  
  • Trend Phase 1 manufacturing data to inform process consistency and improve/qualify scale down models  
  • Draft study designs, standard operating procedures and maintain an electronic lab notebook 

Leadership, cross-functional & communication : 35% of time 

  • Mentor colleagues within upstream process development in support of bioreactor-based program development 
  • Opportunity to directly manage scientists and associates in the near future  
  • Collaborate with process & analytical teams to screen and evaluate drug candidates across a range of indications 
  • Work with internal/external manufacturing groups to transfer clinical processes and support phase 1 manufacturing  
  • Draft technical reports, contribute to IND sections and other regulatory documents 
  • Maintain strong working relationships with external collaborators, vendors and CDMOs 
  • Contribute to a culture that embraces continuous learning, improvement and innovation 
  • Maintains current awareness and contributes to current scientific literature; actively applies new concepts and technologies 
  • Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time 
  Qualifications

Education: 

  • PhD degree in an engineering discipline with 5+ years of experience 
  • Alternatively, a Bachelor’s/Master’s degree in an engineering or life science discipline (Biology, Chemistry, Chemical Engineering, or related) with 10+/6+ years of experience 

Experience: 

  • 5+ years experience with set-up, experimental development and operation of bioreactors for mammalian cells 
  • 4+ years experience with predictive modeling and maintaining online reactor data  

Skills: 

  • Experience with operating and maintaining bioreactor systems 
  • Experience with reactor scale-up and scale-down modes 
  • Experience optimizing and characterizing reactor processes 
  • Strong problem-solving, analytical skills and creativity 
  • Experience in both leading and supporting scientific initiatives  
  • Experimental study design, leveraging past studies and the scientific community 
  • Strong written and oral communication skills with experience presenting scientific information 
  • Excellent time management organizational skills, with ability to handle multiple tasks simultaneously in a high-growth, fast-paced environment 
  • Statistical analysis or numerical methods preferred 
  • Working knowledge of GMP and manufacturing is a plus 

Physical Requirements of the Role:  

  • Ability to work within a regulated Biosaftey Level 2 environment 
  • Occasional bending and lifting of smaller equipment and media (up to approximately 25 kg) 
  • Routine access to/from two adjacent buildings 
  • Primarily computer use and long periods of sitting, standing 
  • Be a lab-based employee of 3+ days onsite 
  • Adhere to 4DMT Covid protocols and policy. This includes all employees and contractors must share proof of current vaccination status to work onsite.  
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
United States
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