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 Upstream Supervisor, you will execute cell culture and/or solution prep unit 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 upstream and solution prep 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:
- Mammalian cell culture processing in flatware/shake flask and adherent/stirred tank bioreactors for both cell expansion and/or vector production
- Cell lysis to harvest AAV
- Depth filtration and tangential flow filtration
- Solve operational tasks in the operation of cell culture processes, including media/buffer prep, cell passaging, bioreactor production, DNA digestion, and harvest clarification operations.
- Cross-trained to different operational areas, e.g., column chromatography using the chromatography system/Unicorn software, and fill/finish with both manual and automated methods.
- 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 cell culture/solution prep 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 cell culture and solutions prep 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.
- 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 technical support in an academic setting.
- Familiarity with cGMP requirements is essential.
- Knowledge of mammalian, insect and viral vector processes. Experience with adherent cell cultures, suspension cell cultures, and/ or disposable single-use adherent/stirred tank bioreactors 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 email@example.com