As Senior Advisor for Science, CMC & Technical Operations I provide strategic and technical consulting on all aspects of product development including regulatory strategy, preclinical development, analytical strategy, CMC and cGMP manufacturing (including outsourcing strategy and oversight) for multiple projects within RRDs portfolio of product development partnerships.

• Directed product development functions for Clearpath Vaccine Co and Nosocomial Vaccine Company, supporting C-level executives in partnership development and project leadership through the sale of the lead asset. • Recruited and managed a team of product development professionals and oversaw outsourced development and manufacturing at five GMP CDMOs.

As part of the Executive Leadership team at FDA licensed-product biologics manufacturer, reporting directly to two CEOs and chairing the executive leadership team between CEOs, I oversaw the Regulatory Affairs, Quality Assurance, Quality Control, Validation Engineering, Quality Systems, Computer Systems Validation and Clinical Data Management groups at MassBiologics. Oversight of 21CFR (cGMP) compliance, assuring the safety, purity and potency of drugs (FDA licensed or IND) produced at MassBiologics. Obtained regulatory approvals for transition of multiple licensed product processes to new facilities. Served as alliance manager for major out-licensing activities. Built MassBiologics CMO business by directing client audit and quality agreement activities. Oversaw validation, FDA submission and approval for new licensed product manufacturing facilities, and led quality and validation functions in design and commissioning of new investigational gene therapy manufacturing facility.

MassBiologics faculty at the University of Massachusetts Medical School contribute to education, scholarship and service through traditional means, such as peer-reviewed publication and research, and uniquely through delivery of translational medicines for in-house clinical projects, as well as with partners and commercial clients. I contributed to innovation and standard setting in professional and industry environments, for example as a contributing author to the Parenteral Drug Association Technical Report No. 56. Application of Phase-Appropriate Quality Systems and cGMP to the Development of Therapeutic Protein Drug Substance, as well as technical reports concerning quality requirements for compounding clinical trial materials, the quality of glass for parental packaging together with ongoing work as a member of PDA's Cell and Gene Therapy Task Force.

JPAC's mission was to determine the fate of US service personnel who remained unaccounted-for as the result of past conflicts. As a civilian scientist I directed technical operations at search and recovery locations worldwide, participated in laboratory analyses of human remains and directed the DNA identification program under which skeletal case work was selected, sampled and submitted for analysis, the results of which I integrated into further casework and case resolution. As an interdisciplinary scientist I was able to serve as an effective technical liaison between the forensic osteologists and the molecular biologists - improving the implementation and effectiveness of technology across traditional professional boundaries. I taught and consulted for numerous international, federal, state, and non-governmental agencies on issues in forensic biology, particularly the recovery of forensic DNA evidence from highly degraded remains. I was part of the management team that led the organization through the transition from the historical US Army Central Identification Laboratory, Hawaii (USA CILHI) into the Joint Command (JPAC) and also the first ever accreditation of a forensic anthropology laboratory by the American Society of Crime Laboratory Directors Laboratory Accreditation Board. I also served as a principle liaison between the CILHI/JPAC and the Armed Forced DNA Identification Laboratory.

• Conducted research in human evolution and taught human evolutionary biology and animal behaviour at the University of Oxford.• Represented student interests as a junior fellow on the governing body of New College.• Co-appointed to multiple faculties/sub-faculties, including Biology, Archaeology, and Anthropology, showcasing interdisciplinary expertise.