Provide technical support for Novasep technologies, Continuous Processing and LP column technologies.

Downstream Clinical Processing

• Accountable for execution of downstream operations in accordance with cGMPs and Quality Systems. (Chromatography steps, UF/DF, viral filtration, column packing and bulk drug fill)• Perform bench scale experiments for development and tech transfer of purification steps into Clinical Manufacturing from the Product Development group. • Serve as Clinical Manufacturing liaison to assure that Standard Operating Procedure (SOPs) and batch records are written to assure maintenance of validated and filed process performance within specifications.• Work closely with Quality and Regulatory department to successfully author and close deviations, corrective and preventative actions and change control.• Possess in-depth knowledge of Unicorn software for chromatography systems ranging in scale from Akta explorer, Akta pilot and Akta process. Responsible for developing and authoring Unicorn chromatography methods for protein purification processes.• Scale up chromatography steps from bench scale to pilot scale; 1cm to 20 cm in diameter. • Analyze and interpret scientific data and work in a cross-functional team with Quality, Regulatory, Validation and Product Development groups to bring new products into the Clinical Manufacturing department. • Provide large scale column packing support and technical support to the Manufacturing department.

• Provided technical support on protein purification processes for GE Healthcare customers (including CSL, Lonza, Genentech, Dr Reddy, Hospira, Glenmark, etc) throughout Asia-Pacific, Australia and the New Zealand regions. • Travelled to customer sites to provide technical support on bioprocess media, chromatography columns ranging in scale form 1 cm to 2 meters in diameter and bioprocess systems.Provided post sale service support to Hospira manufacturing department on 2 one meter Chromoflow columns in Adelaide Australia. Service support included: o Installation and maintenance of two Chromoflow columnso Column packing training to 12 manufacturing scientists & operators and executed on all SOPso Revise and optimize all packing SOPs• Successfully completed a three month rotation to Uppsala, Sweden to support the product launch of the Axichrom column. Axichrom column project responsibilities included; Developing axial compression packing methods for GE Healthcare resin at various diameter (40cm, 60cm, 80cm and 100cm) and at different bed heights (10 cm-50cm) to meet required specification, validate and publish packing procedures. • Supported manufacturing teams at various biotech companies (Amgen, Lilly, Genentech, Wyeth, Merck, etc…) by identifying and troubleshooting GMP manufacturing processes on chromatography media, columns and bioprocess systems.• Scaled up and optimized purification processes by performing studies on chromatography media (flow properties, compression factors, mechanical stability and optimal aspect ratio) and applications (ion exchange, gel filtration, affinity and hydrophobic interaction).Developed, improved, and revised standard operating procedures (SOPs) for purification processes and column packing procedures thru interaction and communication with scientists and engineers within the manufacturing technologies department, followed by execution of the SOPs to ensure required specifications were meet for production.

Operation and testing for recombinant proteins

Synthesis and testing for oligonucleotides