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Director – Analytical Chemistry
Confirmed live in the last 24 hours
Alameda, CA, USA
Experience Level
Desired Skills
Data Analysis
  • Ph.D. in Bio-Analytical Chemistry, Molecular Biology, or other related disciplines and 8 years of experience in gene therapy or gene editing products
  • Significant experience in developing analytical chemistry-based methods for characterization of critical reagents, nanoparticle and viral vectors drug products and process related residuals to advance product understanding, process development and the establishment of control strategies
  • Problem solver with the ability to leverage novel analytical technologies to deeply and broadly advancing Scribe's knowledge of physicochemical and biological properties to support product and process development
  • Experience with critical reagents, raw materials physicochemical properties, functional assays and purity/impurities assays
  • Working knowledge and interpretation of FDA/EMA and ICH regulations and guidelines
  • Demonstrated technical proficiency, scientific creativity, collaboration with department and with drug development groups
  • Strong verbal and written communication skills. Ability to communicate effectively with others internally and externally to the organization
  • Strive for scientific excellence and focus on delivering results
  • People leader
  • Building and leading a team of research specialists and scientists in the Analytical Chemistry Group to design and implement the analytical chemistry methods (biological and physiochemical) and characterization strategies to identify and justify critical quality attributes (CQAs) for Scribe's critical starting materials, drug substance, and drug product
  • Develop phase-appropriate quality control strategy for drug substance and drug product
  • Advanced knowledge and hands-on experience in areas including but not limited to HPLC, CE or LC-MS or ELISA, MSD and ddPCR based techniques to guide process development, process understanding, product characterization, stability, and release testing (Find opportunities for improvement and/or new technology development in drug development-related analytics for implementation)
  • Partnering with process teams to develop the residual clearance strategies for genetic therapies and support the process related residuals methods development
  • Advance scientific understanding of critical reagents, nanoparticle, viral vector based drug products, CQAs and correlation to product efficacy and safety
  • Author and review relevant sections of CMC documentation in support of INDs, CTAs, BLA submissions, amendments, and briefing documents
  • Work with Research, PRe-clinical, Process Science, Quality and Regulatory groups to set appropriate product specifications, develop comparability strategies and support manufacturing investigations
  • Establish regular interface and build strong connections with CDMOs and contract labs
  • Formulate and implement successful CMC and regulatory strategies for drug substance and drug products and pipeline that are fit for purpose, phase-appropriate, and position programs well for approval
  • Strong understanding of global CMC regulatory requirements and industry guidance and provide direction on the interpretation and application of regulations/guidance for gene editing platforms
  • Ensure CMC regulatory strategy is aligned with the Scribe's global development strategy, therapeutic area portfolio, commercial plans, the Target Product Profile (TPP), and Quality target product profile (QTPP)
  • Assist in negotiations with regulatory agencies to resolve CMC issues and foster positive interactions with regulators, eg, pre-IND, end-of-phase, scientific advice meetings, information requests, clinical holds
  • Lead, plan, author, and review CMC submission documents, including agency meeting packages such as Module 3 and Module 2.3 for clinical and marketing applications, supplements, variations, and responses to agency information requests
  • Interface with Quality, CMOs, and other strategic partners * Identify risks and diplomatically propose risk mitigation strategies
  • Build, guide, and invest in the development of a team of direct reports, creating a safe space where they can come as they are and apply their talents to meaningful and satisfying work
  • Review and provide feedback on the work of colleagues, contribute personal expertise to the broader team and be open to learning/cross-training in other areas, lead and develop other team members as needed per our matrix team business model
Desired Qualifications
  • Familiarity with CRISPR technologies and therapeutic approaches
  • Familiarity with protein or RNA structure and engineering approaches
Scribe Therapeutics

11-50 employees