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.
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.
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
- 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
- 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
- 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 email@example.com– should we have a tough-to-fill role, we will contact you directly if you specialize in that area.