Scientific Tech Leader, Analytical Development, Raw Materials Qualification
Editas Medicine, United States

Key Responsibilities amp; Accountabilities:

• Oversee efforts at external test labs to develop analytical methods suitable for testing critical material attributes for raw materials used in the manufacture of critical components, drug substance, and/or drug products in vivo CRISPR and ex vivo CRISPR cell medicines
• Work with Quality, development partners, and internal programs teams to support supplier quality management
• Provide technical expertise for analytical method development for raw material testing supporting in vivo CRISPR and ex vivo CRISPR cell medicines manufacturing internally and at CDMOs for clinical supply through BLA filing and launch
• Collaborate with internal PAD teams to determine critical material attributes and establish raw material testing acceptance criteria
• Review and approve supporting documentation for developed analytical methods
• Perform under supervision raw material risk assessments, including leachables/extractables, and work with PAD teams to evaluate materials for in vivo CRISPR and ex vivo CRISPR cell medicine manufacturing, finding upgrades as appropriate
• Support Quality 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
• Support Regulatory with required information on raw materials for regulatory filings

Requirements

Knowledge, Skills amp; Capabilities:

• Experience working with external analytical development teams and developing strong working relationships with CDMOs and CTLs
• Experience with raw material qualification and supplier quality management programs to support the development, testing and commercialization of 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, including assay qualification/validation, and good documentation practices
• Experience in compendial methodology and multiple analytical techniques: IR, H(U)PLC, GC, LC/MS, Sanger sequencing, ELISA, Westren Blot, cIEF, capillary electrophoresis, PCR (qPCR, ddPCR), SDS-PAGE, and cell-based potency assays
• Previous experience in CGT, oligonucleotides or proteins analytical methods development is desired, but not required
• Knowledge of FDA, EMA and ICH regulations, industry standards and raw material qualification 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
• 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:

• Bachelor’s with 12+ years or Master’s with 8+ in life sciences related discipline, multi-disciplinary experience with multiple years involved in development and technical transfer of analytical methods. At least 3 years of GMP experience is required.

Physical amp; Travel Requirements:

• Occasional domestic travel (~10%)

Job Rewards and Benefits