Key Responsibilities amp; Accountabilities:
This role on the Process and Analytical Development (PAD) team contributes to Editas efforts to develop safe and effective gene therapies using CRISPR-based gene editing technologies.
- Act as the subject matter expert on AAV upstream process development
- Collaborate with contract development and manufacturing organization (CDMO) to support upstream activities during process development, preclinical, clinical and potentially commercial manufacturing
- Responsible for the technical aspect of cell banking for both host cell and plasmid
- Design bioreactor, shake flask, iCellis, cell culture vessel studies at CDMO for AAV upstream process development, characterization and performance qualification and define upstream process control strategies, comparability studies (if needed)
- Lead upstream activity support for technology transfers, scale up and scale down, manufacturing operations and deviations / investigations by designing and executing appropriate studies at CDMO
- Independently design and manage the execution of experiments (DOE) to generate optimal and robust upstream processes at CDMO
- Utilize upstream process derived data (e.g. bioreactors, BGA, metabolite analyzers) and literature research to monitor process performance, support deviation reports and technical investigations and aide in process optimization/development
- Assess impact and facilitate closure of deviations, ensure appropriate scoping of change controls and CAPAs, and develop risk assessments related to upstream processes
- Author and review technical protocols and reports, CMC regulatory sections, process summaries, study design and protocols, SOPs, etc
- Establish routine upstream process data trending activities
- Ensure accurate and complete documentation of any scientific experimental plan, data and report
- Build and maintain good working relationships with internal and external stakeholders e.g. Research, Development, Quality, suppliers, contract manufacturing organizations etc
- Independently analyze data, present results and conclusions to the team
- Improve the understanding, robustness, and economics of commercial manufacturing processes
- Establish and maintain familiarity with contemporary industrial standards, practices, technologies, literature and ways of performing lab studies
Requirements
Knowledge, Skills amp; Capabilities:
- Good understanding of scaling up and scaling down considerations for upstream processes
- In depth understanding and hand on experience in one or more of the following area is required: cell banking, plasmid, bioreactor, iCellis, CellStack, HyperStack, process modeling
- Demonstrated upstream subject matter expertise and hands-on upstream laboratory experience
- Good understanding of biopharma operations, GxPs, ICH guidelines, process characterization, and technology transfer
- Proven project management skills
- Strong communication skills
- Excellent analytical thinking and problem-solving skills
- Knowledge of statistical methods for DOE design and data analysis (e.g. JMP), experience with Quality by Design (QbD) is preferred
- Strong technical writing skills
- Ability to manage multiple tasks and meet deadlines with a high tolerance for ambiguity
- Ability to manage multiple programs in matrix environment
- Ability to lead problem solving for issues related to upstream process development, qualification and validation
- Ability to prioritize project work and make effective use of available resource to meet agreed timelines
- Ability to author and approve comprehensive and accurate protocols/reports
- Ability to select, implement and use appropriate data management concepts and tools
- Ability to function independently and communicate cross functionally across various teams
- Ability to manage priorities, and engage/communicate in a multidisciplinary environment
Education amp; Relevant Work Experience:
- MSc degree (PhD preferred) in a relevant scientific discipline e.g. Bioengineering, Biology, Biochemistry, Virology, with 8-10+ (MSc) or 4-6+ (PhD) years of relevant experience
- Experience in upstream process development and bioreactor operation with viral vectors (2-3+ years) or biologics (4+ years)
Physical amp; Travel Requirements:
- Travel to vendors and CDMOs, as needed (lt;10%)