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 Associate Director (leader of clinical manufacturing), you will support cell culture and/or solution prep in cGMP clinical pilot manufacturing plant operation and assist 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 support the implementation of process improvements/scale-up. Shift/weekend work or lifting 40 lbs. unassisted is required at times.
Summary of Key Responsibilities
- Supervisory responsibilities including performance management for a group of cell culture manufacturing associates/technicians, minimum of one, depending on the expansion progress of new clinical manufacturing plant and company goal.
- Provide hands-on on-the-floor operation for upstream/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
- Depth filtration and tangential flow filtration
- Leverage knowledge and application of the theories and principals utilized to solve operational, as well as routine 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.
- Work with Process Development team, following tech transfer documents, transfer new projects into GMP manufacturing; gain understanding of scientific principles underlying unit operations, and support initiatives for process optimization, identify and elevate processing issues and support 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.
- Generate operational protocol(s), internal documents including SOPs, BPRs, deviations and, if needed, campaign summary reports.
- Troubleshoot cell culture/solution prep processes and equipment problems; work with Facilities to maintain calibration, maintenance and operation requirements of manufacturing equipment.
- Work closely with plant management for planning new manufacturing projects and help develop/scale-up processes/techniques with Process Development to meet timelines and avoid operational delays.
- Ensure manufacturing associates are fully trained on all cGMP manufacturing operations and SOP/BPR documentation, and adhering to operation SOPs and safety guidelines.
- Participate in new facility expansion and equipment validation activities as needed.
- Have a strong understanding of GMP procedure for clinical production of complex biologics.
- Follow all QA procedures, including deviation reporting. Support deviation investigations.
- BS/MS in bioprocessing, chemical engineering, biochemistry or biology with 7-10 years of cGMP manufacturing experience in biopharmaceutical industry.
- Familiarity with cGMP requirements is essential.
- Excellent understanding and knowledge of mammalian, insect and viral vector processes.
- Experienced with both adherent and suspension cell cultures, as well as disposable single-use adherent/stirred tank bioreactors.
- Current understanding and application of best practices related to process hygiene/ microbial control, equipment cleaning, and change-over procedures.
- Excellent time management skills (schedules, timelines, task prioritization) and the ability to multi-task and adapt to changing priorities.
- Ability to thrive and succeed in a team-oriented entrepreneurial environment.
- 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 firstname.lastname@example.org