DS Purification Manufacturing Associate / Sr. Manufacturing Associate

4D Molecular Therapeutics (4DMT), located in Emeryville, CA, is a global leader in gene therapy product research and development using scientific innovation to unlock the full potential of gene therapy for patients with genetic diseases. At 4DMT, our goal is to design and develop transformative gene therapy products using our proprietary adeno-associated virus (AAV) variants platform to treat serious unmet medical conditions.

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 Downstream Supervisor, you will execute chromatography purification and/or fill finish operations in cGMP clinical pilot manufacturing plant operation. You will participate in quality, compliance and safety programs for the daily manufacturing operations of biologic products to support gene therapy clinical trial and product development. In addition, you will participate in the implementation of process improvements/scale-up. Shift/weekend work and  lifting 40 lbs. unassisted is required at times.

Summary of Key Responsibilities

  • 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. Duties include:
    • Column chromatography purification (AKTA Pure, Avant, Pilot systems)
    • Depth filtration and tangential flow filtration
    • Formulation and filling of drug product
  • 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 to different operational areas, e.g., buffer/ media preparation and upstream cell culture of adherent and suspension cells.
  • 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.
  • Complete batch production records under cGMP & tech transfer systems and through the use of SOPs/forms and BPRs for the processes and manufacturing steps to meet both operational and compliance requirements.
  • Contribute to operational protocol(s) and internal documents including SOPs, BPRs, deviations.
  • Troubleshoot downstream/ fill finish processes and equipment problems; work with Facilities to maintain calibration, maintenance and operation requirements of manufacturing equipment. Perform environmental monitoring activities during aseptic processing.
  • Work closely with supervisors for setting the manufacturing schedule to meet timelines and avoid operational delays.
  • Work closely with Materials Management to keep the downstream and fill finish areas stocked with all raw materials/ process inputs.
  • Participate in new facility expansion and equipment validation activities as needed.
  • Have a strong understanding of GMP procedures for clinical production of complex biologics.
  • Follow all QA procedures, including deviation reporting. Support deviation investigations.

Qualifications

  • BS in bioprocessing, chemical engineering, biochemistry or biology with 1-3 years (Associate) or 4-5 years (Sr. Associate) of cGMP manufacturing experience in biopharmaceutical industry. Biotechnology program certifications may be considered, as well as experience providing technician support in an academic setting.
  • Familiarity with cGMP requirements is essential.
  • Knowledge of affinity, ion exchange, and/ or multi-modal purification processes. Experience with UNICORN software, designing single-use, closed-system assemblies, and/or aseptic gowning/cleanroom experience is highly desired.
  • 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 ability to assume leadership-type responsibilities in a growing organization.
  • Familiarity with Excel, Word, and PowerPoint.
  • Excellent written and oral communication skills.
  • Capable of strenuous, repetitive, physical work, including bending, reaching, climbing stairs and ladders, 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.

 

Qualified candidates may submit a resume and cover letter to jobs@4dmt.com