Head of Quality for Kiniksa Pharmaceuticals, spanning over GMP, GLP, GCP, GDP, and GVP quality oversight for the growing company. Kiniksa’s product portfolio of 5+ assets spans late stage discovery through the various clinical stages, with assets moving into Phase III clinical trails. Sole responsible person to establish the overall strategic long term vision for quality at Kiniksa, ranging from establishing the long term detailed hiring and growth plans, identification of specific talent roles needed, establishing the landscape of quality processes and oversight, establishment of quality agreements and overall relationships with key external CDMO/CROs/partners, and inspection roadmaps to the clinical GCP BIMO inspection as well as the PAI associated inspections.

A pharmaceutical company focused on rare diseases, neuroscience, GI, and ophthalmic therapeutics. Products segmented into biologics and small molecules and therapeutic modes ranging from mammalian cell culture, bacterial fermentation, cell therapy and gene therapy, and combination products using devices. Shire is heavily focused on disposable single use production systems for the biologics products. Organizational and various senior leadership roles in sponsoring key significant TechOps projects and/or acting as a lead: External Manufacturing Network CoE, Sponsor and providing vision for the 10 Year Technology Roadmap for TechOps Core Operations, QC Network Strategy, Right First Time and Focused Contamination Control Initiative as well as others. Joined Shire in 2013 at the beginning of a time of dramatic growth for the company, and heavily involved at the top level for various aspects of the growth stage, commercialization of a number of products, acquisition lead teams, and other aspects.Key organizational responsibility in the Global Quality organization for Shire, with operations in various locations in the US and globally. Responsibilities included oversight of both internal and external laboratory operations, lab and quality related technical support, filing and regulatory strategy ownership for the analytical aspects of a product, primary contacts for direct interaction with regulators on analytical or testing topics, central testing laboratories, stability, and various topics of contamination control and microbiology. Total direct organization of 300+ employees with various additional dotted line groups working in close conjunction to the quality organization. Role sits on various Leadership Governance councils: External Manufacturing Oversight, Shire Quality Leadership Team, Global Quality Council, and the Product Development Council for clinical and early phase products.

A Contract Manufacturing Organization specializing in Biotech Active Pharmaceutical Ingredients (Large and Small-scale Mammalian Cell Culture, Development, and Cell Therapy) with projects ranging from CLC/early clinical phase to commercial with representation on the CMC teams for all projects. Responsible for the complete establishment and management of the Quality organization in the three manufacturing facilities constructed in Singapore (two Mammalian Cell Culture API facilities and one Cell Therapy Drug Product facility); greenfield sites with no existing staff from the construction phase through startup/facility validation, through process validation (PV) and into routine production of the facility. Key member of the Lonza Singapore site leadership team, which was heavily involved in routine customer interactions at all levels (from routine, to periodic performance review meetings, detailed planning sessions, etc). With the greenfield projects (3 main facilities in Singapore over the 6 year period), my role was heavily involved in aspects of detailed design and engineering aspects, oversight of construction aspects, supplier selection through the startup in all areas of the facility, in addition to the operations focused role.

Celltrion is a Contract Manufacturing Organization specializing in Biotech Active Pharmaceutical Ingredients (Large Scale Mammalian Cell Culture). Initially responsible for Tech Transfer from a large pharma/biotech companies into Celltrion, South Korean. Established a number of department wide Quality systems in the startup of the facility. Moved into a role of GMP compliance and overall startup Quality support for the facility in areas such as Calibration, Deviation Management, Change Control, and comprehensive preparation for regulatory inspections. Worked to arrange significant cross-functional org and program structures, such as establishing the Customer Program Management Office.

A Contract Manufacturing Organization specializing in Biotech Active Pharmaceutical Ingredients (Small-scale Mammalian Cell Culture and Microbial Fermentation) with projects ranging from CLC/early clinical phase to commercial with representation on the CMC teams for all projects. Manager over the QC analytical testing areas that covered in-process, release, and stability testing for 24/7 operations. Performed the overall technical review for batch disposition and CMC sections for filings for customers.

Responsible for maintaining and genotyping various strains of transgenic mice. Lab analysis of mice genotypes included various molecular biology techniques: PCR, Southern Blots, competent cell preparations and transformations, DNA isolation and purification, and cloning. Other responsibilities involved developing yeast PCR runs and two-hybrid screening programs for protein-protein interaction detection, HPLC and UV Spectroscopy methods analysis.

A biotech company focused on the production of antibodies and antigens used in diagnostic and research platforms. Responsibilities encompassed GMP production and quality control testing of antibody markers and related products. Production involved immunoaffinity chromatography, gel-antigen coupling, and antibody purification. Quality Control activities included HPLC analysis, UV Spectroscopy, SDS-PAGE, and other various QC methods (ex. pH, Appearance). Additional responsibilities also included creating/revising SOP’s, GMP Batch Record verification, and troubleshooting production/purification runs

An Agri-biotech company focused on creating transgenic crops to improve disease/pest resistence and increase global crop yields. GLP laboratory responsibilities included mirco-GUS assays in ELISA format, bacterial transformations, cloning, SDS-PAGE, cell culture, and DNA extraction, HPLC analysis, as well as data analysis and background research. Supported functions associated with the Regulatory Department with filings to various regulatory agencies.