Manager/Senior Manager, AAV Downstream Process Development
Editas Medicine, United States

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 downstream process development
• Collaborate with contract development and manufacturing organization (CDMO) to support downstream activities during process development, preclinical, clinical and potentially commercial manufacturing
• Design chromatographic, centrifugation, filtration studies with CDMO for AAV downstream process development, characterization and performance qualification and define downstream process control strategies, comparability studies (if needed)
• Lead downstream 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) at CDMO to generate optimal and robust purification processes
• Utilize downstream process derived data (e.g. chromatography, filtration, centrifugation) 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 downstream processes
• Author and review technical protocols and reports, CMC regulatory sections, process summaries, study design and protocols, SOPs, etc
• Establish routine downstream 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
• Improve the understanding, robustness, and economics of commercial manufacturing processes
• Independently analyze data, present results and conclusions to the team
• 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 downstream processes
• In depth understanding and hand on experience in one or more of the following area is required: column and membrane chromatography (e.g. affinity, ion exchange), membrane filtration (NFF, TFF, viral filtration), centrifugation, viral clearance study, continuous processing, process modeling
• Demonstrated downstream subject matter expertise and hands-on downstream laboratory experience (e.g. AKTA chromatography and filtration systems)
• 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 downstream 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 downstream process development and chromatography/filtration system operation with viral vectors/vaccines (2-3+ years) or biologics (4+ years)

Physical amp; Travel Requirements:

• Travel to vendors and CDMOs, as needed (lt;10%)

Job Rewards and Benefits