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 an Analytical and Formulation Development Scientist which will be a key technical position within 4D Molecular Therapeutics (4DMT) process sciences team. Reporting to the Director, Process Sciences and serving as an integral member of the CMC team, this individual will be responsible for the development and execution of analytical methods to support method and formulation development, biopharmaceutical formulation development and other development activities 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.
Specific job functions will include, but are not limited to:
• Demonstrated track record with multiple bioanalytical and biophysical assessment techniques for product characterization and product stability evaluation, such as HPLC, SDS PAGE, Spectroscopy (UV/VIS, fluorescence, light scattering, &/or CD), qPCR, immunoassays, process impurity testing and cell-based viral infectivity
• Organized approach to providing a turnkey analytical service in support of process scientists and Pilot Plant operations
• Acquisition of deep subject matter expertise in several such methods, allowing for their improvement and readying for qualification and/or validation
• Awareness of regulatory guidance for bioanalytical method validation and an ability to apply such regulations to assay development
• Relating the analytical characterization of process intermediates and products to the development and execution of manufacturing unit operations
• Conscientious and efficient recording of analytical data, including trend analysis. DOE and authoring of development reports
• Awareness of inventory control for equipment, consumables and reagents
• Ph.D in relevant Biochemistry or Bioengineering, Chemical Engineering with 1-2 yrs industry experience.
• MS or BS in relevant, Biochemistry or Bioengineering, Chemical Engineering with minimum 5 years industry experience required.
• Proficiency in statistical software and DOE is desired
• Experience writing study protocols and reports required
• Experience in development, transfer and validation of viral or protein based analytical methods preferred
• A proven record of innovation, excellent laboratory, data analysis, and critical thinking skills required
• Strong communication skills both written and oral with demonstrated ability to present ideas and information and data effectively via one on one discussions, team meetings
• Excellent time management skills (schedules, timelines, task prioritization) and the ability to adapt to changing priorities.
• Excellent multi-tasking and problem-solving skills; solution-oriented; self-motivated.
• Ability to thrive and succeed in a team-oriented entrepreneurial environment
• Demonstrated knowledge in process development
• 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 with minimal required direction
Qualified candidates may submit their cover letter and cv to firstname.lastname@example.org