Senior Director, Protein, RNP and AAV Process Development
Editas Medicine, United States

This role is critical to Editas’ efforts to develop safe and effective medicines using CRISPR-based gene editing technologies. It requires the capability to collaborate with Research, Tech Ops, and Quality teams to direct the internal and external development and technical transfers of processes for protein, ribonucleoprotein (RNP) complexes, and AAVs to support clinical and commercial manufacturing for novel in vivo CRISPR medicines and ex vivo CRISPR cell medicines. The scope includes comparability and process validation. The ability to support and foster learning and development in a high performing team is critical.

Key Responsibilities amp; Accountabilities:

• Develop sstrong Process Development teams, supporting learning and development opportunities
• Provide strategic leadership and direct the internal PD efforts as well as external PD efforts at CDMOs to develop processes suitable for clinical and commercial manufacturing of CRISPR endonucleases, RNPs, and AAVs for in vivo and ex vivo medicines
• Direct effective technical transfers of developed processes to internal manufacturing or CDMOs using best practices
• Foster collaboration with Analytyical Development on formulation development, developing effective process control strategies, assessing processes, and providing process representative material for analytical development efforts
• Direct establishment of process understanding, design space, and CPPs and development of strategies for process comparability and process validation, ensuring preparation and approval of comprehensive supporting documentation for developed processes and process control strategies
• Ensure team engagement and participate in cross-functional CMC and program teams to drive in vivo CRISPR medicines and ex vivo CRIPSR cell medicines through clinical development efficiently and effectively
• Provide technical support for manufacturing materials for clinical supply and commercial manufacturing
• Author, review, and provide strategic guidance, technical expertise, and process knowledge support during the preparation of regulatory filings
• Support efforts in the generation and testing of materials for IND-enabling activities and regulatory submissions, including toxicology, reference standards, assay qualification, lead stability, forced degradation studies, and engineering runs
• Ensure Quality is supported with required data, technical assessments, and expertise, including assisting with trending data for management reviews, change controls, CAPAs, deviations, stability plans, specifications, OOS results, and assay validation
• Maintain awareness of the literature, technologies, and industrial landscape of biologics and gene therapy
• Develop and manage budget, resourcing planning, and strategic planning for protein, RNP, and AAV process development
• Other responsibilities as required

Requirements

Knowledge, Skills amp; Capabilities:

• Experience managing process development teams and developing strong working relationships with CDMOs
• Experience developing, manufacturing, and commercializing biologics and gene therapies, including preparation of documents for submission to regulatory agencies
• Experience with statistical data analysis in development, including design of experiments (DoE), and process validation
• Advanced knowledge of FDA, EMA and ICH regulations, industry standards and quality control principles for cGMP operations
• Understanding of product development life cycle and stage gates from research to clinical development to commercial operations
• Ability to interpret and analyze data, define problems, establish facts, draw valid conclusions, and make decisions and deal with abstract and concrete variables in situations where only limited standardization exists
• Ability to work with others to troubleshoot complex technical and scientific problems while showing sufficient independence in execution and thought processes
• Exceptional organizational skills with the ability to multi-task and prioritize assignments, strong problem-solving skills, self-motivated with ability to work under pressure to meet deadlines
• Team focused, demonstrate high level of integrity, and have strong collaboration, communication, interpersonal and organizational skills
• Ability to diversify technical skillsets in a fast-paced organization

Education amp; Relevant Work Experience:

• Master’s or PhD in life sciences related discipline with 12+ years of multi-disciplinary experience with multiple years involved in development and technical transfer of protein and AAV manufacturing processes for clinical development

Physical amp; Travel Requirements:

• Travel to support technical transfer efforts, as required

Job Rewards and Benefits