Act as person in plant during manufacturing operations, address technical and quality issues, and perform drug product and drug substance batch record review to assure GMP compliance prior to provision to QA for releaseWork closely with LJPC’s internal Development team and external manufacturing partners to define, optimize, scale, and validate stage appropriate manufacturing processesLiaise with Regulatory Affairs and Quality Assurance on CMC items, author and review SOPs and CMC/Quality-related regulatory correspondence and submissions to support clinical and/or commercial programs Manage all CMC aspects of product development and routinely interface with other departments, such as Analytical, Preclinical, Clinical, Development, Regulatory, Project Management, Quality Assurance and Quality Control

Directed and managed general product development efforts in CMC, clinical and non‐clinical developmentLiaised between CMO’s, Regulatory, Quality, Clinical Operations, Nonclinical sites, consultants and internal functional areas to ensure the company’s efforts conform to corporate goals and quality requirementsContributed extensively to Regulatory Affairs filings via document creation/review and worked with the all functional groups to ensure readiness for regulatory filings as per corporate schedulesSupported Quality System and contributed to Quality with respect to audits, SOP’s, CCB, etc.

Managed CMC development, manufacturing and testing for gene therapy viral product and extended release tablet product candidates at contract manufacturing organizationsServed as Man in Plant during manufacturing campaigns and addressed technical and quality issuesEstablished Quality Systems, managed GXP Compliance Audit and Supplier Qualification programs and advised GXP regulated functions in the development and improvement of quality management activitiesPrepared CMC regulatory documents supporting US and foreign submissions

Responsible for Quality oversight of CMC development, manufacturing and distribution activities of OraVerse® at contract service providersAuthored/reviewed quality records relating to analytical and product development, manufacturing, validation and stability activitiesDeveloped GXP Quality Systems and resolved quality issues ensuring compliance to regulatory guidelinesSupported Regulatory Affairs via document creation and review and maintained compliance to foreign/federal/state regulations

Provided regulatory strategy and advised product teams for investigational drug, biologic and combination productsServed as a liaison between Company and regulatory agencies (CBER and CDER)Wrote and reviewed eCTD regulatory submission documents such as INDs, NDAs and related regulatory updates and facilitated eCTD lifecycle management Generated project management timelines and process flows

Managed GXP Quality System Programs and Quality oversight of CMC development, manufacturing and validation activities of the company’s lead drug candidate, Riquent™Facilitated internal and regulatory audits and addressed observations during PAI and due diligence auditsSupervised and trained a staff of QA Associates to ensure consistent review of manufacturing documentationSupported manufacturing and process development in authoring, review and approval of NDA, MAA, IND and other regulatory submissionsInvestigated, purchased, and implemented commercially scaled synthesis, purification, and down stream processing equipment for the manufacture of LJP’s lead drug candidate and served as a key member in designing a commercial manufacturing facility with class 100,000 clean-room for synthesis, purification, ultra-filtration, and downstream processing.Designed small scale synthesis, purification and analytical method modifications to investigate drug candidates, engineering strategies for scale-up of purification and isolation processes for clinical protein based drug candidate

Supported the development and manufacturing of oligonucleotide APIs Responsible for the synthesis, purification and analysis of 20-mer oligonucleotides