This pharmaceutical company develops and commercialises innovative respiratory devices for the safe and reliable delivery of pharmaceutical cannabinoids. By combining regulated cannabinoid therapies with their unique inhalation technologies, we can bring safe, reliable and quick relief to patients who live with cancer and those who endure chronic pain.
They are looking for an enthusiastic, proactive and dedicated Process Development Engineer to join their dynamic team. This is a small, fast-paced organisation where timely decision-making and action-taking is essential. To succeed you will need to be willing to apply your knowledge and experience to new areas and have a passion for bringing their innovative products to market.
Your skills and experience
- Bachelor or higher in a relevant area (Industrial Engineering or similar) at least 5 years of relevant experience in the industry
- Proficient with data handling, analysis, and technical reporting
- Critical thinker with a logical approach
- Ability to create a clear structure in an ambiguous environment
- Experience with pressurised formulations and/or formulations for inhalation
- Know-how of standards, guidelines and regulations regarding quality systems and GMP guidelines and processes for pharmaceutical R&D and production
- Knowledge of QBD principles and their application to new product development
- The ability to operate in new and evolving regulatory environments
You will be responsible for introducing and managing the processes that convert our pipeline from R&D into scalable commercial products.
Responsibilities:
- Design, manage and deliver on process development activities for the production of drug formulation canisters and final product
- Work with and manage external third-party service providers
- Develop work plan and schedule, in collaboration with relevant team members
- Set up of manual production facilities, where needed, for the manufacture of drug formulation
- Define, implement and manage scopes of work for process verification and validation activities, against relevant regulations and guidelines
- Review results and outcomes in alignment with the project goals, identify causes of variances and recommend solutions to achieve goals
- Author high-level technical protocols/reports and present technical data to all levels within the organisation.
- Participate in process improvement projects to improve product quality, decrease cost, and improve product performance
- Work with third-party service providers to enable scale up in production
- Communicate business and technical needs, status, results and observations
- Undertake patent searches, complete freedom to practice assessments and generate new intellectual property
- Plan, organise, assist/lead formulation and product feasibility assessments in line with organisational requirements
- Keep abreast of relevant industry news and activity