James Killory Email & Phone Number

Sydney, Australia

Technical Lead for region with hubs in India, Thailand, South Africa, Japan, and Australia-New Zealand. Responsible for technical oversight of contract manufacturers in the region. Principal areas of responsibility include technology transfers, GMP remediation, validation strategy and execution, significant investigations, and change controls. Technologies.

Batam, Indonesia

Head of process technology team supporting a large contact lens manufacturing facility. Areas of responsibility included project management, process improvement, data analysis, calibration and metrology, and support of investigations and troubleshooting. Technologies included terminal sterilization, clean-room engineering, low-pressure plasma coating.

Chesterbrook, PA

Senior Principal Engineer and Scientist and interim head of a central services 7-person pharmaceutical manufacturing group. Shire Specialty Pharma produces all of its clinical and commercial products using CMOs. The DPMS&T group supports technical changes, process improvements, technology transfers and validations, and investigations at Shire's CMO partners.

Puurs, Belgium

Responsible for strengthening supply network by enhancing quality and technology-based systems and the interface between API suppliers and its DP consumers.

US (New Jersey) And Southeast Asia (Thailand)

Experienced pharmaceutical professional with more than 30 years of applicable experience in all aspects (Sterile, Fermentation, API, and Drug Product) of pharmaceutical manufacturing technology. Strong qualifications for process troubleshooting, start-ups, technology transfer, qualification and validation, and process optimization. Lengthy multinational.

Singapore

Responsible for Technical Support, New Product/Process Tech Transfers, Chemistry R&D - including Pilot Plant -, Technical Training, Validation, and PAT, and technical support for a 1000-person strong site making active ingredients, oral doses, inhaled aerosols and powders, and sterile injectables.

Singapore

Directed manufacturing of active ingredients in operation comprising 3 facilities, and 16 processing areas. Successfully introduced a major new product, including expansion of its manufacturing capability. As process area owner, brought on-line a significant new facility.

Kenilworth, NJ

Responsible for representing manufacturing division in technology transfer support and decisions, particularly as it applies to active ingredients. Particular emphasis on GMP compliance for FDA consent decree work. Direct contributor to corporate standards for Technology Transfer, Process Validation, and Facility Design.

Syracuse, New York

Responsible for management of a pilot plant chartered with making active ingredient supplies for clinical trials and regulatory filings. Process specializations include enzyme, fermentation, natural product isolation, and organic-synthetic manufacturing. Particular emphasis on plant cell fermentation and isolation of cytotoxic active ingredients

Manager responsible for assembly, commissioning, qualification, and post-sale service of production-scale and pilot-scale and bench-scale automated preparative HPLC systems and HPLC-based purification apparatus. Worked closely with client to specify, design, and put into service custom prep HPLC units that met the users' requirements in a regulatory.

Indianapolis, Indiana, United States

Process Engineer supporting production-scale chromatography equipment supplier

Elkton, VA

Technical Operations engineer in support of manufacturing initiatives. Particular emphasis on technology transfers, yield and cost optimizations, and process improvement changes. Specific capability in production-scale chromatography, solids-handling, solvent recovery, and active ingredient isolation. Designed, constructed, and operated pilot-scale process.

Corning, NY

Central Engineereing-based Chemical Engineer supporting major initiatives in manufacturing. Projects include bench-scale immobilized fermentation process development, high-temperature ultra-pure glass deposition, precious metals recovery and refining, chemical processing of photosensitive glass-ceramics, and troubleshooting of glass-ceramics quality issues.

Syracuse, New York

Microbiologist supporting virology laboratory-scale operations. Experience in microbial, mammalian, algal, and viral culturing. Experience in laboratory animal handling. All aspects of sterile operations and small-scale lyophilization. Emphasis on environmental virology.

M.S., Chemical Engineering

Research project on protease activity in E. coli

B.S., Chemical Engineering

B.S., Biology

Emphasis on microbiology