Member of the Mammalian and Microbial Manufacturing Business Unit, Technical liason between Sales, Commercial and Lonza internal technical teams. Responsible for potential new customer proposals, BLA and sBLA work scope generation for mammalian biologics, covering development and manufacturing opportunities in Europe, the US and Asia.

The DSP Process Engineering Group is a group within Lonza whose main focus is to investigate and evaluate new technologies within the biotechnology industry with the purpose of alleviating the growing bottleneck at the purification stage of product manufacture which is arising from high titer cell lines and increasing bioreactor volumes.Projects have involved evaluation of new technologies in viral inactivation and high throughput screening of ion exchange chromatography resins, chromatography membranes and disruptive and non-chromatographic purification techniques.

Responsible for the technical transfer and process optimization of a customer's purification process from their facility to Lonza's 5kL and 20kL manufacturing areas.Provided process training and supported manufacturing operators in the facility to aid transition of the customer's process.Managed and performed a scale down process comparison study to model and predict large scale peak profiles and collection volumes immediately prior to large scale processing Developed process validation protocols and will implemented studies during development runs to support the customer's sBLA applicationResponsible for writing and approving GMP documents required for product manufacture including purification process description, processing and column packing batch records.

Gained significant experience using G.E. Healthcare (formerly Amersham Biosciences) UNICORN software, AKTA FPLC/Explorer and Bioprocessor skids, ultimately for increased throughput for purification process development and pilot scale production.Responsible for validation of process limits for a customer's purification process. Increased throughput of study runs, resulting in a 50 - 60% reduction of the study timeline. Sole responsibility of purification process development for a new antibody therapy for a large pharmaceutical customer. Managed budget and coordinated work according to timelines set by project management whilst reporting to senior management and external customer against aggressive 8 week timeline.Responsible for training staff on use of laboratory equipment and techniques to GMP standards.Coordination and operation of a 400L pilot purification for scale up to 20,000L scale. Responsible for composition of raw materials list, overseeing buffer preparation and purification processing against an aggressive timeline.

Experienced in ISO 9000 standards, performed the manufacture, purification and in-process enzymatic assaying of a variety of biochemical products manufactured by the company. Working knowledge of 3 different freeze drying facilities of varying size and automation.Developed extensive knowledge and expertise of HPLC and large-scale chromatographic techniques.Identified and performed risk assessments for situations within the department.Selected and trained to become a designated First Aider.Nominated to be the Responsible Person which in the absence of a Team Leader required responsibility and supervision of other staff members, all products in process, cooling systems, effluent storage levels, freeze dryer statuses.

Worked to ISO 9000, GMP and GLP standards.Manufactured bulk materials for the production and in-process testing of immunodiagnostic test kits , all of which are used to detect syphilis positive human serum. Performed Quality Control duties to ensure the bulk materials used in these kits were within the stated specifications. Involved in the production and testing of immunofluorescent detection slides, and the coating of ELISA plates.