Gary Gordon Email & Phone Number

Wuxi, Jiangsu, Cn

Wuxi, Jiangsu, Cn

• Lead for the Manufacturing Science and Technology (MSAT) department of the WuXi Biologics Organization based in Dundalk.• Responsible for Technology Transfer, Process Validation (PPQ, CQV) and Technical Studies to support commercial manufacturing. • Building the newly formed MSAT function in Dundalk establishing team identity and roles and responsibilities.• Setup of the new MSAT laboratory in Dundalk and execution of first small scale runs to support product transfers.

San Rafael, Ca, Us

• Product Lead for two Enzyme Replacement Therapy (ERT) commercial drug programs.

San Rafael, Ca, Us

• Manufacturing Science and Technology (MSAT) team o Building a high performing team of creative thinking professional scientists aligned to the business strategy through the development of organisational goals and objectives, prioritisation of projects and linking all key functions.• New Product Introduction Program Managero Overall program manager for new product introduction to the Shanbally facility leading a multi-disciplinary team to restart the Fed Batch Cell Culture Facility. End to end responsibility from equipment design through to Process Validation and Regulatory Approval.• Laboratory Services Manager o Assumed responsibility for the laboratory services group supporting MSAT and QC laboratories

Raritan, New Jersey, Us

Raritan, New Jersey, Us

• Principal Scientist within the Global Technical Services division of Janssen Supply Chain•Leading new product introductions to the Cork facility, including a portfolio of products at various stages from pre-clinical through to commercial production.•Responsible for overall project management of new product introductions.•Technical owner – Technical lead for all drug substance aspects of the process (upstream and downstream) across two facilities (Ireland and the Netherlands).

Raritan, New Jersey, Us

• Leading a team of scientists for the development of an early stage monoclonal antibody. Working in a highly dynamic matrix environment to design, execute and document a robust process for clinical manufacturing. • Providing technical oversight on all areas associated with cell culture and purification including: use and analysis of DOE for demonstration of process robustness and setting process parameters, interpretation of stability studies for determination of intermediate hold times, resin cleaning/lifetime studies and supporting viral clearance studies, technology transfer, process characterization and validation, and technical documents for regulatory authorities including CMC sections of regulatory submissions. • Responsible for managing and meeting extremely aggressive timelines for development work, in conjunction with both internal and external customers while producing a process that is fully designed for manufacturing

Us

• Support and lead process Tech Transfers into Cork manufacturing (clinical and commercial)• Responsible for purification area, introduction of new products, routine batch execution, process safety, technician training, area compliance, process improvements, scheduling, trouble shooting. • All projects executed right first time and fully aligned with site master production schedule.• Ensure that technical issues related to process manufacturing are addressed.• Support and implement Process Validation Studies on site. • Area Mistake Proofing champion, implementation of Kepner Tregoe methodology to site.

Us

• Extensive expertise in process validation, technology transfer, cleaning validation and process support validation.• Responsible for the planning and execution of technology transfer, scale-up, manufacturing start-up and process validation activities. • Technical lead to ensure that purification issues are addressed and that processes are aligned with operational capabilities.• Responsible for monitoring, data interpretation and technical reporting of purification process performance.• Provided technical input and documentation for regulatory inspections and submissions.

New York, New York, Us

• Product development chemist working in a high containment facility producing cancer treatment drugs.Experience in scale-up, continuous improvement and validation.Trained in six sigma techniques, yellow belt certified, developed successful black belt project leading to substantial product quality improvements and cost reductions. •Spent six months as a production facilatator working in the production department on continuous improvement projects.

Higher National Diploma, Leadership Development

Doctorate, Organic Chemistry

Bsc (Hons), Environmental Chemistry