Manufacturing Specialist

GENERAL SUMMARY: 

4DMT is in need of a motivated, team-oriented, and experienced Manufacturing Specialist. This individual will join a small but skilled manufacturing team to deliver novel AAV vectors for gene therapy clinical trials. The Manufacturing Specialist will interface with Process Development to transfer new candidates into GMP production, and provide support for experiments as needed.  

RESPONSIBILITIES: 

• Execute upstream and solutions preparation 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: 

• Mammalian cell culture processing in flatware/shake flask and adherent/stirred tank bioreactors for both cell expansion and/or vector production 
• Transfection 
• Cell lysis to harvest 
• Depth filtration and tangential flow filtration (TFF) 

• Act as SME in cell culture processes, including media/buffer preparation, cell passaging, bioreactor production, DNA digestion and harvest clarification operations. SME will be required to:  

• Lead investigations related to upstream manufacturing operations and report/present to stakeholders, as needed. 
• Generate operational protocol(s) and internal documents including remediation and investigation plans, SOPs, master batch records, deviations. 
• Perform and lead risk assessments, gap assessments and change controls as it relates to implementing process changes 

• Cross-trained to different operational areas, e.g., column chromatrography using chromatrography system/UNICORN software and fill/finish with both manual and automated methods. 
• Engage and 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 to meet both operational and compliance requirements. 
• Troubleshoot 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 solution preparation 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 procedure for clinical production of complex biologics. 
• Follow all QA procedures, including deviation reporting. Lead deviation investigations. 
• Shift and/ or weekend work may be required 

QUALIFICATIONS: 

Education: 

• BS in bioprocessing, chemical engineering, biochemistry or biology preferred 
• Biotechnology program certifications considered, as well as experience providing technician support in an academic setting. 

Experience: 

• At least 10 years of cGMP manufacturing experience in biopharmaceutical industry  

Skills: 

• 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.  
• 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 provide leadership in a growing organization. 
• Proficient with Excel, Word, and PowerPoint. 
• Excellent written and oral communication skills. 

Physical Requirement 

• 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. 
• Pass a visual acuity test and color blindness test with or without corrective lenses.  

Bay Area Range:  $130,000/yr - $176,000/yr

Please note that compensation varies on a variety of factors including experience, location, etc.