Senior Process Development Associate - Virus Production
4D Molecular Therapeutics, located in Emeryville is a global leader in gene therapy product research & development using scientific innovation to unlock the full potential of gene therapy for patients with genetic diseases. At 4D Molecular Therapeutics, our goal is to design and develop transformative gene therapy products using our proprietary adeno-associated virus variants platform to treat serious unmet medical conditions. We are seeking a talented and motivated Senior Process Development Associate to join our team in developing processes for viral gene therapies and producing virus for preclinical studies.
This individual will be responsible for the production of preclinical drug products for in-vitro and in-vivo screening for R&D and will be expected to participate in process development for all stages of 4DMT’s portfolio of viral therapeutics. This individual will have a high level of passion for 4DMT’s mission and the ability to operate as an effective strategic as well as tactical thinker.
Candidates should have a bachelor’s degree in Biology, Biochemistry, or other relevant discipline with 5+ years of working experience in the biotechnology industry. This experience should include expression and purification of virus or biologics from mammalian expression systems. Experience with bioreactors and hands on experience with AKTA purification systems is also required. The individual will have an organized and systematic approach to viral or biologic production, as well as a track record of collaborative relations with groups such research & development, analytical development and pilot plant operations. Ability to multi-task and meet tight timelines is essential.
Responsibilities include but not limited to:
• Production of viral gene therapy products, including upstream cell culture, downstream purification, and limited analytical testing
• Cell line maintenance and development, including both adherent and suspension mammalian cell culture systems
• Transfection optimization
• Downstream process development, including column chromatography, cell lysis, clarification, and TFF unit operations
• Support of pilot plant, scale-up, and CMO tech transfer as needed
• Managing and scheduling production runs and process development work
• Awareness of inventory control for equipment, consumables and reagents in preparation for unforeseen requests
· BS in relevant, Biology, Biochemistry or Bioengineering, Chemical Engineering with minimum 5 years’ industry experience
· Experience expressing and purifying virus or biologics in an industry environment using mammalian cells lines is essential. Specific experience with AAVs is desirable.
· Experience working with GE Akta systems and Unicorn software, including troubleshooting, writing/editing methods, and optimization is required.
· Experience with mammalian cell line development, optimization, and scale up (ie WAVE Bioreactors) is desirable.
· Experience working in (or awareness of) a GLP/GMP environment is advantageous but not required.
· Strong written and oral communication skills with demonstrated ability to present scientific ideas and information and data effectively via one-on-one discussions and team meetings.
· 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 are required and basic statistical analysis techniques are preferred
· Ability to interact well with other groups and must be able to take ownership of and follow through on assignments
· Must be able to support multiple assignments simultaneously and independently