Senior Scientist, Gene Delivery and Editing Process Development

Responsibilities

• Design, execute, and troubleshoot upstream development experiments supporting next-generation LVV and AAV production
• Identify, onboard, and develop novel upstream technologies in collaboration with internal and external partners
• Optimize production processes and support clinical and commercial scale-up
• Design, execute, and lead a platform development strategy, including coordinating the work of junior colleagues and peers
• Craft and articulate timelines and resource projections
• Communicate progress, risks, and opportunities to senior leaders
• Support cross-functional development efforts (downstream process development, analytical development, pilot plant production, high-throughput process development)
• Support research-to-development transitions, including early-stage/pipeline molecular assessment activities
• Support late-stage process development activities including process characterization
• Participate in lab maintenance, buildout, and continuous improvement initiatives
• Work independently and within teams to design, execute, and analyze experiments
• Summarize and present data in group meetings and contribute to team strategy
• Represent GDPAD within cross-functional teams
• Support tech transfer and on-going activities with external collaborators and service providers (CDMOs, CROs)
• Author detailed technical reports, study memos, and internal and external presentations/publications
• Maintain accurate and detailed laboratory notebook

Basic Qualifications

• Degree in biological or chemical engineering, biochemistry, or bio-related field
• PhD with 1+ year relevant industry experience; MS with 5+ years; BS with 7+ years relevant industry experience
• Subject matter expert with suspension culture of mammalian cells in shake flasks and stirred tank bioreactors
• Subject matter expert in process development
• Expertise in viral vector process development
• Working knowledge of scale up parameters for stirred tank bioreactors
• Proven ability to design experiments with DoE approaches, execute DoE designs and interpret results
• Independently motivated with ability to work in cross-functional teams
• Experience interfacing with contract manufacturing and development organizations
• Ability to communicate clearly and concisely through oral presentations and technical writing
• Ability to leverage literature, internal and external resources to solve problems
• Desire to identify and advance the cutting edge
• Growth mindset and ability to thrive in a fast-paced, highly collaborative environment
• Experience giving presentations at industry conferences
• Experience establishing industry and/or academic collaborations

Preferred Qualifications

• Experience with upstream processes intensification e.g. fed batch and perfusion development, process-analytical technology (PAT)
• Experience with cell line development
• Experience with media and feed development and optimization
• Experience with process modeling, mechanistic modeling, and statistical interpretation of results
• Knowledge of metabolic flux and metabolic control analysis
• Experience with data pipelines and knowledge management
• Experience with late-stage development
• Track record of intellectual property generation

Additional Job Requirements

• Position Handles Hazardous Materials
• Position may require occasional travel (e.g. up to 10%)