Sr. Manufacturing Associate

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 not your “everyday” manufacturing opportunity -- in this new and important role, your hands-on operation experience in cGMP biologic manufacturing will help facilitate 4D’s road to a pivotal point in its history – a fully integrated biopharmaceutical company with cGMP clinical manufacturing and future commercial facility.   

Reporting to the Manufacturing Supervisor, you will execute AAV vectors purification and/or solution prep unit operations in the cGMP clinical manufacturing plant. You will participate in quality, compliance and safety programs for the routine manufacturing of biologic products to support gene therapy clinical trials and product development. In addition, you will participate in the execution of technology transfer and the implementation of process improvements/scale-up. Shift/weekend work or lifting 40 lbs. unassisted is required at times.   

RESPONSIBILITIES:  

GMP Manufacturing: 60% of TIME

• Execute downstream and fill finish unit operations for the manufacture of AAV vector products in a cGMP environment, using proper aseptic technique, good documentation practices, and sound scientific methods. Operations include: 

• Column chromatography purification (AKTA Pure, Avant, Pilot systems) 

• Depth filtration and tangential flow filtration 

• Formulation and filling of drug product 

• Manual visual inspection 

• Solve operational tasks in the operation of purification processes, including column packing, UNICORN method writing, filtration assembly design, and aseptic filling via manual and automated processes. 

• Cross-trained in different operational areas, e.g., buffer/ media preparation and upstream cell culture of adherent and suspension cells. 

• Troubleshoot downstream/fill-finish processes and equipment problems. Lead deviation investigations and identify CAPAs as necessary. 

Routine GxP Support: 25% of TIME

• Contribute to and author and complete Master Batch Records under cGMP & tech transfer documentation and use SOPs/forms and MBRs for processes and manufacturing steps to meet both operational and compliance requirements. 

• Contribute to and author and review operational protocol(s) and internal documents including SOPs, MBRs, deviations, qualification protocols and summary reports. 

• Work with Facilities/IT to maintain calibration, preventative maintenance, and operation requirements of manufacturing equipment. Perform environmental monitoring activities during aseptic processing. 

• Work closely with management for setting the manufacturing schedule to meet timelines and avoid operational delays. 

• Collaborate with Materials Management to ensure current and new (if executing tech transfer) raw materials and process inputs are in-stock. 

• Follow all QA procedures, including deviation reporting. Support deviation investigations. 

Continuous Improvement: 15% of TIME

• Support the Process Development team in transfer of new projects and scale-up of processes into GMP manufacturing. Identify and elevate processing issues (large and small) and implement solutions.  Provide feedback and/or suggested changes to operational procedures. 

• Participate in compliance projects and process or equipment qualification activities as needed.  

QUALIFICATIONS: 

Education:

• BS in bioprocessing, chemical engineering, biochemistry or biology 

• Biotechnology program certifications or Associates may be considered, as well as experience providing technician support in an academic setting. 

Experience:

• 3+ years of cGMP manufacturing experience (Specialist) 

Skills:

• Proficiency with cGMP requirements is essential. 

• Knowledge of affinity, ion exchange, and/ or multi-modal chromatography 

• Knowledge of tangential flow filtration 

• Familiarity UNICORN software and designing single-use assemblies is highly desired. 

• Aseptic gowning/ cleanroom experience is preferred. 

• Excellent time management skills and the ability to multi-task and adapt to changing priorities. 

• Ability to thrive and succeed in a team-oriented entrepreneurial environment and provide leadership in a growing organization. 

Physical Requirements of the Role:

• Capable of strenuous, repetitive, physical work, including bending, reaching, climbing stairs and ladders, standing for long periods of time, kneeling, and making numerous equipment connections using hands. Independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 40 pounds. 

• Capable of passing a near vision visual acuity test (with or without corrective lenses) and color blindness test 

• Shift and/ or weekend work may be required 

 

Base salary compensation range: 

 

Minimum: 

Maximum: 

Bay Area Range 

$93,000 

$106,000 

 

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: the candidate’s geographical location, relevant work experience, skills, and years of experience. 

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