Will Issa Email & Phone Number

Melbourne, Vic, Au

Melbourne, Victoria, Australia

Expansion of my role from R&D Manager to now include API Production as well is a further increase in responsibility and affords me end-to-end oversight of internal and client projects across the business. As part of this role all R&D and process development, transfer and scale up of projects to the manufacturing suites and their execution to cGMP standards is within my remit and scope.

Melbourne, Victoria, Australia

Management of R&D development team with responsibility over development, scale-up, tech transfer and validation activities for all new product development and existing portfolio projects across the business. This position expands on my role as a key SME for all technical support, investigations and continuous improvement opportunities, and includes significant client liaison on external projects to ensure that clients needs are met by delivering projects on time to the highest standards.

Melbourne, Victoria, Australia

My role at IDT is quite diverse and has me involved with many aspects of the business. As a technical subject matter expert my focus is the evaluation and development of new processes and their transition into commercial manufacture, this includes involvement with the recent mRNA projects and development of the medicinal cannabis processes. I remain heavily involved with continuous improvement initiatives across the site and continue to lead quality investigations, risk assessments and process optimisations. I began this role predominantly in a continuous improvement capacity, introducing initiatives like Quality by Design to the site. As part of this role I made significant contributions to the team responsible for remediation activities that resulted in the lifting of the FDA warning letter in 2019; including leading the team conducting forensic analysis of electronic lab data and and addressing the agencies queries on data integrity. This work has facilitated strategic expansions by the company, which includes projects involved with recommissioning of the sterile manufacturing suite and mRNA vaccine manufacture. Outcomes from these projects include being awarded a sterile license after a successful TGA audit and the successful completion of the first Australian based mRNA vaccine (in collaboration with MIPS and the Doherty institute) which is currently in phase 1 clinical trials.

Mulgrave Australia

As a research scientist at Hospira I was able to lead projects evaluating new technologies like controlled nucleation for lyophilization and was able to develop a Quality by Design model for legacy products. I remained heavily involved with the product investigations and was able to expand this aspect of my role, applying my problem solving skills to issues identified with current manufacturing processes as well as the product specific work I had been previously doing. My role included the investigation, root cause analysis and proposal of corrective actions for major product deviations across the site, risk assessment of new customer products and processes, and the identification of continuous improvement opportunities for the site. In this role I was able to lead a team that evaluated Controlled Nucleation methodology for lyophilisation at scale. I also developed a Quality by Design model for legacy products that ensured the current manufacturing process continued to produce a safe and efficacious product and was beginning to introduce process analytical technologies to the site.

Mulgrave, Australia

Hospira is the world’s largest manufacturer of generic injectables. My role at Hospira involves the technical evaluation of new projects coming into the company, as well as the development of improved chemical entities and new innovative products. This role primarily focuses on project specific problem solving. As part of this role I have significant exposure to and have regular interaction with all aspects of the business, including QC, Stability, Formulation, IP, Manufacturing, Regulatory and Clinical. These interactions have enabled me to broaden my core medicinal chemistry experience to include all aspects of drug development up to and including product registration and project management

Melbourne Australia

Avexa’s business is the discovery and development of anti-infective pharmaceuticals for the treatment of serious human infectious diseases like HIV. This role focused on synthesis and discovery of non nucleoside based inhibitors of HIV integrase.