$200K - $250K(Ladders Estimates)
Individual will be responsible for directing the analytical development efforts for IVERIC bio's AAV Gene Therapy programs, including management of contract testing laboratories and oversight of contract manufacturing organizations. Individual will lead the analytical validation of methods including review of protocols/reports/audit of data. Individual will work in conjunction with manufacturing, regulatory and quality to initiate stability protocols and review data in support of regulatory submissions.
Individual will provide subject matter expertise and leadership in the development of analytical methods for AAV product release testing and product characterization. Primary responsibilities include overseeing the method development, qualification, and transfer to support process development and product release, as well as directing product characterization studies to support regulatory filings.
Individual will have experience in directing the development and validation of molecular biology test methods not limited to PCR (qPCR, ddPCR), Viral Infectivity, ELISA, SDS Page, Capillary Electrophoresis, AUC, and cell based potency assays at external sites.
· Oversight of contract testing labs and contract manufacturing organizations in developing, qualifying, and validating analytical assays for AAV products to support process development and QC release
· Lead the effort in AAV product characterizations
· Act as a CMC lead in analytical development team, lead the design and execution of comparability and stability studies for multiple programs
· Manage and participate in tech transfer of analytical methods
· Develop and deliver scientific presentations, participate in project teams, provide leadership in CMC team, and contribute to regulatory filings
o Oversee development, validation and execution of methods that are suitable for the release and stability of AAV based gene therapy products in support of clinical manufacture.
· Technical lead for GMP method development, validation, method transfer, data analysis and reporting.
· Ensures compliance with GCP, GLP and cGMP
· Author and review assay development and validation reports, relevant sections of documents pertaining to AAV analytical methods development and documentation for submission to regulatory agencies.
Requirements· Previous management of contract testing facilities and contract manufacturing organizations
· Experience setting specifications based upon statistical analysis
· Excellent technical writing skills and editing of technical reports.
· Thorough knowledge of GMPs, ICH, USP, EP
· Review of deviations, OOS, OOT, and change controls
· Experience authoring CMC regulatory filings (IND, CTD and IMPD)
· In-practice knowledge of the ICH for assay qualification and validation
· Experience in managing outsourced analytical development and working with external contract labs (CMOs, CROs)
· Experience in the development biologics is required
· Experience in leading CMC team/sub-team, managing CMC activities in analytical development is required
· Experience with viral vectors is preferred
· Strong project management skills and experience leading assay development in support of regulatory filings
· Strong, demonstrated ability to thrive in a fast-paced biopharmaceutical environment
· Prior experience in developing and validating methods in a GMP/GLP environment.
· Experience with writing validation protocols, validation reports, relevant sections of regulatory documents, IND, IMPD and BLA
· Excellent technical writing and communication skills; able to articulate complex scientific concepts to diverse functional groups and external stakeholders.
· PhD in Analytical Chemistry, Biophysics, Biochemistry, or a related discipline with 5+ years industry experience
Valid Through: 2019-10-18