• Ensured high-quality and on-time submissions, including for early and late-stage INDs, IMPDs, CTAs and BLAs for complex biologics, that align with company strategies and health authority requirements. This includes strategic planning and assisting with writing the CMC dossier towards specific submission milestones (early to late phase) and interacting with cross-functional departments to ensure deliverables are met according to the corporate goals.• Strategically planned and assisted with writing responses to CMC-related inquiries from regulatory health authorities.• Prepared information packages and ensured cross-functional team readiness for health authority CMC interactions.• Provided regulatory and scientific expertise in review of CMC source documentation to support dossiers.• Provided oversight of detailed regulatory assessments for global CMC changes.• Represented Regulatory Affairs CMC on working groups and teams.• Developed relationships with and proactively communicated issues with key internal colleagues.• Developed and implemented best practices based on current and emerging industry trends, and relevant Health Authority guidance and regulations.• Created, communicated. and implemented global submission strategies.

• Accountable for generating global regulatory CMC documentation (IND, CTA, CTD, NDA, BLA, MAA) and query responses to support the investigational and commercial registration/post-approval of biopharmaceutical products including monoclonal antibodies, bi/tri-specifics, antibody-drug conjugates, bacterial proteins, synthetic oligonucleotides and PEGylated peptides and proteins. Experience spans Phase 1 through BLA and post-approval.• Provided regulatory strategy and risk assessments to technical project development teams for biopharmaceutical products throughout the drug development lifecycle. Experience includes generating regulatory strategies for introducing changes throughout development and post-approval as well as streamlining late-stage development work (i.e., utilizing bracketing and matrix designs for ICH stability and process validation) to support commercial registration.• Prepared documentation for and lead regulatory meetings with various health authorities. This experience spans pre-IND meetings through pre-BLA meetings and includes scientific advice and technical consultations.• Developed, implemented and maintained documentation repositories for regulatory and supportive documentation. Experience includes supporting migration of documentation from various repositories to Documentum based systems.• Generated and implemented regulatory CMC source document and registration templates. Experience includes creating CMC submission templates and “submission ready” study report templates based on CMC submission templates.• Represented Regulatory CMC Biologics on due diligence initiatives for potential in-license products. This includes providing strategically based CMC regulatory feedback to prospective project and regulatory teams on candidate products.

• Drafted technical documentation related to process development of biopharmaceutical products including study reports and technical design specification documents.• Provided documentation to support regulatory submissions.• Managed and coordinated various project areas within biopharmaceutical development teams and organized cross-functional team efforts specifically for spray drying, filling and packaging.• Investigated process alternatives to support process enhancement of biopharmaceutical products including upstream fermentation and bioreaction as well as downstream purification.• Developed biologics processes and transferred technical work to support biopharmaceutical products.

• Responsible for research and development of biorefining processes for the petroleum industry especially focused on novel separation techniques including multi-phase emulsions and biocatalysts.• Responsible for incorporating design parameters into the construction, operation and control of novel biological pilot plants, including aseptic operation.• Co-invented and authored U.S. patents and invention disclosures, including issued patent No.: 5,772,901 “Oil/Water/Biocatalyst Three Phase Separation Process”.