Massachusetts Green Jobs

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 & 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 & 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 & Travel Requirements:

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