The Technical Manager & Writer (CMC and non-clinical Toxicology) for Gene Therapy will interact with internal multidisciplinary teams to ensure coordination and management of Chemistry, Manufacturing, and Controls (CMC) and non-clinical toxicology activities. He/She will support these activities by authoring and subsequent maintenance of technical documentation related to the development of Ocugen’s innovative modified gene-therapy products. Such activities will include authorship, subsequent maintenance, and revisions of SOPs, technical procedures, protocols, and reports including stability related to laboratory operations, development and validation activities, toxicology studies, manufacturing processes and analytical methods. The incumbent will collaborate with internal and external cross-functional department colleagues to ensure successful execution of company’s business strategies and company objectives.
What You Will Be Primarily Responsible For:
- Authoring, analyzing, and interpretation of CMC, non-clinical toxicology and pre-clinical efficacy related technical data (from development reports, SOPs, Batch Records, Reports, etc.) to author Pre-INDs, INDs and IMPD sections, briefing documents, and other documents needed to support regulatory interactions and filings for CMC.
- Authoring of Orphan Drug Designation (ODD) requests based on the pre-clinical efficacy data and disease prevalence and submitting to FDA for the ODD designation in collaboration with regulatory partners
- Performs quality control (QC) and editorial review of documents prepared by other team members for completeness, accuracy, consistency, structure, and grammar.
- Reviews and aids in responding to requests for information from regulatory agencies, as required.
- Manages the review and approval of documents needed for regulatory filings.
- Performs literature search on new discovery programs and authors new project proposals in collaboration with Discovery Scientists.
- Manages and communicates document-specific timelines to team members to ensure on-time deliverables are completed.