Senior Director, Analytical Development
Editas Medicine, United States
Job Description
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 internal Research, Tech Ops, and Quality teams to direct the internal and external development of analytical methods for gene editing critical components, drug substance and drug products to support clinical and commercial manufacturing for novel in vivo CRISPR medicines and ex vivo CRISPR cell medicines. This involves development of analytical methods for CRISPR endonucleases, ribonucleoprotein (RNP) complexes, plasmids, AAVs, and various gene-edited cell therapies. This role fosters collaboration with Research on new and second generation analytical methods, Process Development on formulation development and process control strategies, and Quality. The scope includes supporting characterization testing, comparability protocols, and analytical method validation. The ability to support and foster learning and development in a high performing team is critical.
Key Responsibilities amp; Accountabilities:
- Develop strong Analytical Development teams, supporting learning and development opportunities
- Provide strategic leadership and direct the internal development as well as external efforts at CDMOs and CTLs to develop fit for purpose analytical methods suitable for clinical and commercial manufacturing and testing of in vivo CRISPR medicines and ex vivo CRISPR cell medicines and critical components
- Foster collaboration with Research and Quality on new and second generation analytical methods, directing effective technical transfers from Research and to internal Quality Control or CTLs using best practices
- Foster collaboration with Process Development on formulation development, developing effective process control strategies, and assessing processes
- 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
- Direct the preparation and approval of comprehensive supporting documentation for developed analytical methods
- Author, review, and provide strategic guidance, technical expertise, and analytical method 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 analytical development
- Other responsibilities as required
Requirements
Knowledge, Skills amp; Capabilities:
- Experience managing internal and external analytical development teams and developing strong working relationships with CDMOs and CTLs
- Experience developing, testing and commercializing biologics and gene therapies, including preparation of documents for submission to regulatory agencies
- Experience in managing assay development and analytical testing for biologics or gene therapy products. Familiar with control charting, assay life-cycle management, assay qualification/validation, and good documentation practices.
- Experience with biophysical, cell-based assays, molecular assays, and flow cytometry methods
- Experience with statistical data analysis in development, including design of experiments (DoE)
- 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 organizatio